System and method for producing dental solutions incorporating a guidance package

ABSTRACT

A method of producing a retention piece having a guidance package configured to provide a desired movement profile including: obtaining data descriptive of mandibular and maxillary arches, an index position of the mandibular arch at a maximum closure position, and a temporomandibular joint of a recipient; specifying an appropriate guidance package based on the desired movement profile; positioning a retention piece comprising at least a portion of the specified guidance package about virtual representations of at least one of the mandibular and maxillary arches within a virtual articulator; modeling relative movement of the virtual representations of the mandibular and maxillary arches within the virtual articulator; and generating data that can be used by a computer aided machining (CAM) process to create at least one physical retention piece comprising the specified guidance package configured to provide the desired movement profile.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/240,900 filed 26 Apr. 2021, which is a continuation of U.S. patentapplication Ser. No. 16/329,549 filed 28 Feb. 2019, now U.S. Pat. No.10,987,872 issued on 27 Apr. 2021, which is a U.S. National StageApplication of, and claims the benefit pursuant to 35 U.S.C. § 371 of,International Patent Application No. PCT/US2017/049545 filed 31 Aug.2017, which claims priority to U.S. Provisional Patent Application No.62/382,106 filed 31 Aug. 2016, the entire contents and substance ofwhich are incorporated herein by reference in their entirety as if fullyset forth below.

TECHNICAL FIELD

The various embodiments of the present disclosure relate generally tosystems and methods for producing oral retention pieces having guidancepackages to provide a desired movement profile for the mandibular archin relation to the maxillary arch.

BACKGROUND

Dentists are often faced with the problem of trying to change themovement of a patient's mandibular arch with respect to their maxillaryarch. For example, a new index position of the mandibular arch to themaxillary arch may be established to solve a number of problems. Adifferent movement profile to a different index position may be used toaddress different problems, such as bruxism, sleep apnea, andTemporomandibular Dysfunction (TMD). Also, a new movement profile to anew index position is often prescribed by dentists when optimizing,rehabilitating, reconstructing, or restoring the stomatognathic systemto include the jaws and teeth.

For example, bruxism is an involuntary or habitual grinding of theteeth, typically during sleep, which undesirably causes many dental andmedical problems. Bruxism has been known to cause myo-facial painsyndrome, damage to teeth, and damage to the temporomandibular joints(TMJs). Incorrect or inadequate treatment of bruxism can amplify itseffects. Many types of night guards have been designed to help addressthe negative impacts of bruxism. Some night guards simply cover theteeth to prevent wear, while others aim to correct the centric relation(CR)/centric occlusion (CO) discrepancy to allow the TMJ to relax in itsmost anatomically appropriate and best stress bearing position (centricrelation for most patients. Other night guards provide anteriorguidance, which, among other benefits, significantly reduces theinappropriate muscle force associated with bruxism and guides the jaw toavoid posterior interferences. Generally speaking, night guards protectthe teeth, address the CR/CO discrepancy, and provide anterior guidance,as failing to address all three aspects can often increase the severityof bruxism.

Traditionally, dental professionals have constructed customized nightguards, which are typically attached to the maxillary and/or mandibularteeth, by hand. The customized night guard allows the dentalprofessional to consider a patient's particular malocclusion and otherfactors to place the patient's jaw in centric relation or anotherpredetermined index position (a new prescribed maximum closureposition).

Another condition, obstructive sleep apnea is caused by an airway thatis restricted. Often this condition can be treated with an oralappliance. Certain appliances may address this condition by changing theindex (e.g., resting) position of the mandible in regard to the maxillato a more protrusive position in a closing or closed position to keepthe mandible anterior in relation to the maxilla to also therefore pullthe tongue anteriorly to also therefore open the airway. For example, asleep apnea appliance may change the position of the mandible to aprescribed protrusive orientation (new maximum closure position) by aprescribed route.

As another example, TMD (temporomandibular dysfunction), may beexpressed in a number of ways that will cause pain and further damagefor the patient if left untreated. Often this condition can be treatedwith an oral appliance. This appliance may preclude the mandible frommovement that would put stress on the damaged area of one or both TMJs,or in general change the index position of the mandible to the maxillaand the movement profile to that new indexed position as part of a TMDtreatment.

Another example circumstance would be optimizing, rehabilitating,reconstructing or restoring the stomatognathic system to include thejaws and teeth. Many patients suffer a major CO centric occlusion/CRcentric relation discrepancy due to a malocclusion or other issue. Inother words, the jaw position when the teeth or arches closed togethermay be incompatible with the patients' TMJs or may be in conflict withsome other aspect of the stomatognathic system. When a dentist is in theprocess of a patient optimization, rehabilitation, reconstruction orrestoration, it may be advantageous for the patient to change thisproblematic maximum intercuspation position (index position of themandible to the maxilla in the maximum closure position) and themovement profile to that different position. This may involvemodification of the maxillary and/or mandibular arch. The dentist maymodify the tissue of the arch with the use of restorative, surgicaland/or implant placement guides. The dentist may provide restorationsthat when the teeth or arches are closed together, this new position andthe continuum of guidance to this different position is now compatiblewith the patient's TMJs (or to correct some other circumstance ofincompatibility in the stomatognathic system).

These example appliances, restorations, and restorative/surgical/implantplacement guides may be effective, and may guide the patient's mandibleto a new maximum closure position by a prescribed route. However, in therelated art, it typically requires substantial time and effort to createand modify the appliances, restorations and surgical/restorative/implantplacement guides for a particular patient. Bruxism appliances, TMDappliances and sleep apnea appliances in the related art may also be oflimited use for patients with missing or periodontally weakened teeth orspecific malocclusions, and only provide limited anterior guidance.

The inventor of the embodiments described herein has invented numerousguidance packages and systems for making and using guidance packages toprovide a number of desired movement profiles, which are described inU.S. patent application Ser. Nos. 13/573,283, 13/774,033, 13/774,920,13/918,754, 14/083,467, and 14/748,805, which are incorporated herein byreference in their entireties as if fully set forth below. However, manyrelated art solutions suffer from some of the issues discussed above inthat it can be difficult to customize a guidance package to a particularpatient in an efficient manner.

Accordingly, there is a need for improved systems and methods to addressthe above mentioned deficiencies. Embodiments of the present disclosureare directed to these and other considerations.

SUMMARY

The present disclosure relates to systems and methods for producingretention pieces having a guidance package to correct a movement profileof a patient. The movement profile may be corrected to appropriatelyguide the patient's mandible to a new index position (e.g., a rest, ortherapeutic assigned position) of the mandible in relation to themaxilla (e.g., a new maximum closure position).

According to an example embodiment, there is provided a method ofproducing a guidance-equipped solution configured to provide a desiredmovement profile for the mandibular and maxillary arches of a recipientrelative to each other, the method including: obtaining data descriptiveof the mandibular and maxillary arches, an index position of themandibular arch with respect to the maxillary arch, and one or moreboundaries of a three-dimensional region; specifying an appropriatevirtual guidance package based on the desired movement profile, thevirtual guidance package associated with a movement profile; positioningthe specified virtual guidance package in virtual space; parameterizingthe positioned guidance package across the three-dimensional region tocreate at least one virtual guidance equipped solution; and generatingdata that can be used to create at least one physical guidance-equippedsolution configured to provide the movement profile associated with thespecified virtual guidance package for the mandibular and maxillaryarches relative to each other.

The method may further include generating a virtual model of themaxillary and mandibular arches, and the specified virtual guidancepackage may be positioned in virtual space within the virtual model.

The method may further include customizing the specified virtualguidance package by adjusting at least one of a size, position, andorientation of the specified virtual guidance package within the virtualspace, creating a customized movement profile, and the at least onephysical guidance-equipped solution may be configured to provide thecustomized movement profile for the mandibular and maxillary archesrelative to each other.

The boundary of the three-dimensional region may include tissue surfacesof at least one of the mandibular arch and the maxillary arch.

The boundary of the three-dimensional region may include a regionembedded within surfaces of at least one of the mandibular arch and themaxillary arch.

Parameterizing the positioned guidance package across thethree-dimensional region may provide a plurality of virtual guidanceequipped solutions formed across a spectrum.

The plurality of virtual guidance equipped solutions may include aplurality of synergistically shaped guidance solutions each configuredto provide the movement profile associated with the specified virtualguidance package.

The parameterizing may include forming a series of virtual guidanceequipped solutions designed to progressively or correct damage of therecipient.

The at least one virtual guidance equipped solution may include at leastone of a surgical guide, a restorative guide, and an implant placementguide for at least one of the mandibular arch and the maxillary arch.

The surface of the three-dimensional region may define a maximumpossible depth of the surgical guide, restorative guide, and implantplacement guide.

The physical guidance-equipped solution may include a therapeuticdevice.

The therapeutic device may include a clear-aligner type orthodonticappliance.

The method may further include selecting a virtual guidance equippedsolution from the at least one virtual guidance equipped solution basedon a desired response from a neuromuscular system of the recipient.

The method may further include selecting a virtual guidance equippedsolution from the at least one virtual guidance equipped solution basedon appropriate curves of occlusion for the recipient.

The at least one virtual guidance equipped solution may include aretentive piece for one of the mandibular and maxillary archescomprising surfaces configured to interact with tissue of the other oneof the mandibular and maxillary arches to provide the movement profileassociated with the specified virtual guidance package for themandibular and maxillary arches relative to each other.

The method may further include generating the data descriptive of theone or more boundaries of the three-dimensional region based on the datadescriptive of the mandibular and maxillary arches.

The method may further include generating a virtual model of themaxillary and mandibular arches, and the boundary of the threedimensional space may be embedded within surfaces of at least one of thevirtual mandibular arch and the maxillary arch.

The method may further include identifying a desired form of the atleast one virtual guidance equipped solution, and the created at leastone virtual guidance equipped solution may conform to the desired form.

The method may further include generating the data descriptive of theone or more boundaries of the three-dimensional region based on the datadescriptive of the mandibular and maxillary arches and the desired formof the at least one virtual guidance equipped solution.

According to some example embodiments, there is provided a computerreadable apparatus may have stored thereon computer program code forperforming one or more of the methods described herein.

According to an example embodiment, there is provided a method ofproducing a retention piece having a guidance package configured toprovide a desired movement profile for the mandibular and maxillaryarches of a recipient relative to each other, the method including:obtaining data descriptive of the mandibular and maxillary arches, anindex position of the mandibular arch with respect to the maxillary archat a predetermined maximum closure position, and at least onetemporomandibular joint of the recipient; specifying an appropriateguidance package based on the desired movement profile for themandibular and maxillary arches relative to each other; positioning avirtual representation of a retention piece comprising at least aportion of the specified guidance package about virtual representationsof at least one of the mandibular and maxillary arches within a virtualarticulator; modeling, with the virtual representation of the retentionpiece positioned about the at least one of the mandibular and maxillaryarches, relative movement of the virtual representations of themandibular and maxillary arches within the virtual articulator todetermine whether the specified guidance package provides the desiredmovement profile, the relative movement resulting from the guidanceprovided by the virtual representation of the specified guidancepackage; and generating data that can be used by a computer aidedmachining (CAM) process to create at least one physical retention piececomprising the specified guidance package configured to provide thedesired movement profile.

The appropriate guidance package may be specified from a plurality ofguidance packages, each preprogrammed to provide a different movementprofile.

The data descriptive of the at least one temporomandibular joint may bespecific to a temporomandibular joint of the recipient.

The method may further include using a three-dimensional printer tocreate the at least one physical retention piece based on the generateddata.

The method may further include selecting a transverse, sagittal andfrontal size for the specified appropriate guidance package based on atleast a portion of the data.

The retention piece may include at least one from among of a denture ora partial denture comprising at least a portion of the guidance package,a crown comprising at least a portion of the guidance package, and abridge comprising at least a portion of the guidance package.

The retention piece may include a guidance component including a concaveportion surrounded by a bumper-shaped perimeter dimensioned to preventlips of the recipient being pinched by the guidance component when therecipient closes his mouth.

The method may further include scaling the specified guidance package,based on at least a part of the obtained data, and the virtualrepresentation of the retention piece may include the scaled specifiedguidance package.

The method may further include: positioning a virtual representation ofanother retention piece comprising at least another portion of thespecified guidance package about the virtual representations of theother of the mandibular and maxillary arches within the virtualarticulator; and modeling, with the virtual representation of theretention piece and another retention piece positioned about themandibular and maxillary arches, relative movement of the virtualrepresentations of the mandibular and maxillary arches within thevirtual articulator to determine whether the specified guidance packageprovides the desired movement profile, the relative movement resultingfrom the guidance provided by the virtual representation of thespecified guidance package.

The at least one physical retention piece may be configured to providethe desired movement profile based on interference with at least aportion of tissue in a mouth of the patient.

The method may further include creating the at least one physicalretention piece utilizing at least one of additive and reductive CAMtechnologies.

The data that can be used by a CAM process to create at least onephysical retention piece may include data that can be used to create aplurality of physical retention pieces for progressively treatingdamage.

The at least one retentive piece may include a therapeutic device.

The therapeutic device may include a clear-aligner type orthodonticappliance.

According to some embodiments, there is provided a method of producing aretention piece having a guidance package configured to provide adesired movement profile for a recipient. The method may includeobtaining data descriptive of: (1) the recipient's mandibular andmaxillary arches, (2) an index position of the mandibular arch withrespect to the maxillary arch of the recipient at a predeterminedmaximum closure position, and (3) at least one temporomandibular joint.The method can further include modeling movement of virtualrepresentations of the mandibular arch with respect to the maxillaryarch of the recipient within a virtual articulator based at least inpart on at least a portion of the data, and specifying an appropriateguidance package based at least on the data and a desired movementprofile for the mandibular arch relative to the maxillary arch.

The method may further include generating one or more virtual pointsbased on one or more of the index position and a position, orientation,or position of one or more of the retentive pieces. A virtual guidancepackage may be positioned in virtual space based on the one or morevirtual points. In some cases, the one or more virtual points indicatenot only position, but also orientation of the virtual guidance packagerelative to one or more of the retentive pieces (e.g., virtual retentivepieces). The guidance package may include a virtual maxillary guidancecomponent and a virtual mandibular guidance component. After positioningthe guidance package in virtual space, the virtual maxillary guidancecomponent may be connected to the virtual maxillary retentive piece toform a first part of a virtual AGP equipped splint. Similarly, thevirtual mandibular guidance component may be connected to the virtualmandibular retentive piece to form a second part of the virtual guidancepackage equipped appliance.

The method may further include positioning a virtual representation ofat least one retention piece including the specified guidance packageabout the virtual representations of the mandibular and maxillary archeswithin a virtual articulator at a position achieving a desired movementprofile. The method may further include modeling relative movement ofthe virtual representations of the mandibular and maxillary archeswithin a virtual articulator to ensure the desired movement profile isachieved, the movement resulting from the guidance provided by thevirtual or mathematical representation of the specified guidancepackage. The method can further include customizing the movement profileusing patient specific data.

In some embodiments, the guidance package derived appliance may be anappliance that provides three-dimensional control, guidance and limitsto the front end of the mandible. The guidance package may be indexedwithin a wide range in the frontal, sagittal and transverse planes inthe retentive piece system to produce a superior, seamless guidancepackage derived appliance for the bruxism patient, a sophisticatedTemporomandibular Disorders (TMDs) guidance package derived applianceproduced with specific jaw repositioning and guidance limitations asprescribed by a dental professional, or a mandibular protrusiverepositioning sleep apnea appliance. The guidance package derivedappliance may have a unique ability to provide anterior guidance in theretentive piece system within a broad transverse, frontal and sagittalrange to include anterior to the teeth therefore enhancing themechanical advantage over the muscles of mastication. The guidancepackage derived appliance can provide three-dimensional anteriorguidance to the jaw and the elimination of posterior interferences(e.g., collisions) without any limitations due to the conditions,malocclusion, presence, or absence of the teeth (e.g., anterior teeth).The guidance package may be indexed and then attached to retentivepieces within the retentive piece system, not directly to the teeth orarch. The guidance package derived appliance may provide this guidanceto the jaw with a minimal vertical dimension penalty when the jaw is incentric relation (CR) because the guidance package may be placedanterior to and independent of teeth. The guidance package derivedappliance may provide unprecedented control of the anterior guidance andlimitations of the jaw to the operator because the selection (or design)of guidance by the dental professional is three dimensional and may beindependent of teeth.

In some embodiments, the disclosed guidance package may reduce patienttime required to initially receive a guidance package derived applianceor to obtain a new guidance package derived appliance when the previousone becomes worn out or damaged. Certain embodiments of the disclosedmethods may minimize the time and effort of both the patient and thedentist to get a new guidance package derived appliance speciallydesigned for the patient. Using a virtual articulator and CAD (ComputerAided Design)-CAM (Computer Aided Manufacturing) technology combinedwith a guidance package, a dental professional can provide, to apatient, a guidance package derived appliance that can be produced froman unprecedented wide range of three-dimensional guidance and limitparameters. Digital records from the patient can be analyzed and then,taking advantage of the flexibility of the guidance package system, aplethora of design possibilities regarding guidance and limits for themandible dependent upon the dental professional's goals for that patientcan be realized. When combined with data from, for example, a Jaw MotionAnalyzer, these appliances may be highly accurate to a particularpatient. According to some embodiments, there is provided a method forproducing, as non-limiting examples, a superior, seamless guidancepackage derived bruxism appliance, a sophisticated TMD guidance packagederived appliance produced with specific jaw repositioning and guidancelimitations as prescribed by a dental professional, or a mandibularprotrusive repositioning sleep apnea appliance.

According to some embodiments, there is provided a method ofautomatically producing or reproducing a customized guidance packagederived appliance for a patient with or without a severe malocclusion.The method may combine Virtual Articulation technology, Jaw MotionAnalyzer technology and/or CAD-CAM methods with the unique attributes ofthe guidance package system and retentive piece technology. The methodmay enable a patient with or without a severe malocclusion and bruxismto receive a customized guidance package derived bruxism appliance, asophisticated customized guidance package derived TMD appliance producedwith specific jaw repositioning and guidance limitations, or a guidancepackage derived mandibular protrusive repositioning sleep apneaappliance automatically without visiting the dental professionalrepeatedly.

The disclosed methods can be applied to a wide range of stock guidancepackages, and/or stock guidance packages that are subsequently modified,and/or a custom designed guidance package for a specific patient and aspecific purpose. The guidance package could be any of a wide selectionof sizes, shapes or styles to address a very wide range of problemsand/or malocclusions. The maxillary component and/or the mandibularcomponent of the guidance package can be designed or modified to any ofa wide selection of shape, size, or style either individually or as agroup to achieve the effect the operator desires. For instance, a TMDtherapist will have available an unprecedented range of optionsregarding both limits and guidance to the mandible. In contrast to othersystems, the guidance package system can provide a wide range ofthree-dimensional anterior guidance, and limits to the mandible and maybe independent of the condition, position, presence or absence of teeth.Also, the position of the guidance package (and therefore guidance andlimits of the mandible) within the guidance package retentive piecesystem can be controlled to maximize or minimize different properties toinclude increase or decrease of the mechanical advantage over themuscles of mastication of the guidance package derived appliance.Considering the unprecedented three-dimensional selection and designpotential of the guidance package system, and the extreme flexibilityregarding the position of the guidance package within the guidancepackage retentive piece system, the CAD-CAM guidance package derivedappliance, the CAD-CAM TMD guidance package derived appliance, andCAD-CAM sleep apnea guidance package derived appliance are far superiorto existing night guards, TMD appliance systems, or sleep apnea systems.

The method can further include a parameterization of the customizedmovement profile whose boundary is an envelope region and selection ofdifferent synergistically shaped guidance packages. The method canfurther include generating data that can be used by a computer aidedmanufacturing (“CAM”) process to create at least one physical retentionpiece including the specified guidance package to achieve the desiredmovement and stop profile.

In some embodiments of the present disclosure, the method can furtherinclude using additive technologies such as the three-dimensionalprinter and/or reductive processes such as CNC routing, laser cutting,or water jet cutting to create the at least one physical retentionpiece.

In some embodiments of the present disclosure, the method can furtherinclude selecting a transverse, sagittal and frontal size for thespecified appropriate guidance package based at least in part on atleast a portion of the data.

According to some embodiments, there is provided a system for producinga retention piece having a guidance package to provide a desiredmovement profile for a recipient. In an example embodiment of thepresent disclosure, the system can include at least one processor and atleast one memory. The at least one memory can include instructions that,when executed by the processor, cause the system to perform the varioussteps of the one or more methods described above. For example, theinstructions may, when executed by the processor, control the system toobtain data descriptive of (1) the recipient's mandibular and maxillaryarches, (2) an index position of the mandibular arch with respect to themaxillary arch of the recipient at a predetermined maximum closureposition, and (3) at least one temporomandibular joint.

The at least one memory can further include instructions that, whenexecuted by the processor, cause the system to allow an operator of thesystem to model movement of virtual representations of the mandibulararch with respect to the maxillary arch of the recipient within avirtual articulator based at least in part on at least a portion of thedata. The at least one memory can further include instructions that,when executed by the processor, cause the system to allow an operator ofthe system to specify an appropriate guidance package based at least onthe data and a desired movement profile for the mandibular and maxillaryarches relative to each other.

In some cases, the instructions may, when executed by the processor,instruct the system to identify one or more virtual points to position avirtual specified guidance package in virtual space in relation to avirtual representation of one or more retentive pieces. In some cases,the one or more virtual points may identify both a location on the oneor more retentive pieces and a relative orientation of the specifiedguidance package. In some cases, the one or more virtual points may bespecified or modified by an operator of the system (e.g., a dentalprofessional). The instructions may provide a user interface for thespecification or modification of the virtual points by the operator.

The at least one memory can further include instructions that, whenexecuted by the processor, cause the system to allow an operator of thesystem to position a virtual representation of at least one retentionpiece including the specified guidance package about the virtualrepresentations of the mandibular and maxillary arches within a virtualarticulator at a position achieving a desired movement profile.

The at least one memory can further include instructions that, whenexecuted by the processor, cause the system to allow an operator of thesystem to model relative movement of the virtual representations of themandibular and maxillary arches within a virtual articulator to ensurethe desired movement profile is achieved, the movement resulting fromthe guidance provided by the virtual and/or mathematical representationof the specified guidance package.

The at least one memory can further include instructions that, whenexecuted by the processor, cause the system to allow an operator of thesystem to customize the movement profile using patient specific data.

The at least one memory can further include instructions that, whenexecuted by the processor, cause the system to allow an operator of thesystem to conduct a parameterization of the customized movement profilewithin a bounded envelope region (a virtual three-dimensional (3D)region) and selection of different synergistically shaped guidancepackages. In some cases, the virtual 3D region may include space forgeneration of one or more retentive pieces, the guidance package, andall other functions of the guidance package system, and may be referredto as a global 3D region.

The at least one memory can further include instructions that, whenexecuted by the processor, cause the system to generate data that can beused by a CAM process to create at least one physical retention pieceincluding the specified guidance package to achieve the desired movementprofile.

In some embodiments of the present disclosure, the memory can furtherinclude instructions that, when executed by the processor, cause thesystem to use additive and/or reductive CAM technologies to include the3D printer to create the at least one physical retention piece.

In some embodiments of the present disclosure, the memory can furtherinclude instructions that, when executed by the processor, cause thesystem to allow an operator of the system to select a transverse,sagittal and frontal size for the specified appropriate guidance packagebased at least in part on at least a portion of the data.

In some embodiments of the present disclosure, the appropriate guidancepackage can be specified from a plurality of guidance packages, eachpreprogrammed to provide a different movement and stop profile.

In some embodiments of the present disclosure, the data descriptive ofthe at least one temporomandibular joint can be specific to atemporomandibular joint of the recipient.

In some embodiments of the present disclosure, the data descriptive ofthe at least one temporomandibular joint can be descriptive of a generictemporomandibular joint.

In some embodiments of the present disclosure, the retention piece caninclude one of a denture or a partial denture including at least aportion of the guidance package.

In some embodiments of the present disclosure, the retention piece caninclude a crown including at least a portion of the guidance package.

In some embodiments of the present disclosure, the retention pieceincludes a bridge including at least a portion of the guidance package.

In some embodiments of the present disclosure, the guidance package caninclude at least one protrusion extending away from the retention piece,the protrusion having a geometrical shape that causes the mandibulararch to move in the desired movement profile when the protrusionmechanically contacts a surface of the other of the mandibular andmaxillary arches or another retention piece in contact therewith. Theguidance package or movement and stop profile may be a virtualrepresentation and/or a mathematical object.

In some embodiments of the present disclosure, the retention pieceincludes prosthetics that may include one or more of a crown, bridge,removable partial denture (“RPD”), denture, other fixed or removableprosthetics, and combinations thereof.

In some embodiments of the present disclosure, the retentive pieceincludes an appliance that may be smoothly flowing plastic or othermaterial that may include one or more of a bruxism appliance, sleepapnea appliance, TMD appliance, or other therapeutic, restorative, orprotective appliance. In some embodiments of the present disclosure, theguidance package solution to include a defined space (envelope region)may enable creation of surgical guides, restorative guides, and implantplacement guides. In some embodiments, a surface of the retentive piece(for example, a device to define an envelope region) located within thetissue for defining an envelope region serves as the base of both thatparameterization but also the limit of potential modification of tissue.In other words, in some embodiments, the envelope region not onlydefines the defined space for parametrical consideration of a guidancepackage solution, but also may dictate to what depth surgical,restorative and implant placement guides may be used to modify tissue.

These and other aspects of the present disclosure are described ingreater detail in the Detailed Description with reference to theaccompanying figures. Other aspects and features of example embodimentswill become apparent to those of ordinary skill in the art uponreviewing the following description of specific, example embodiments ofthe present disclosure in concert with the figures. While features ofthe present disclosure may be discussed relative to certain embodimentsand figures, embodiments of the present disclosure can include one ormore of the features discussed herein. Further, while one or moreembodiments may be discussed as having certain advantageous features,one or more of such features may also be used with the variousembodiments. In similar fashion, while example embodiments may bediscussed below as device, system, or method embodiments, it is to beunderstood that such example embodiments can be implemented in variousdevices, systems, and methods of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The following Detailed Description is better understood when read inconjunction with the appended drawings. For the purposes ofillustration, there is shown in the drawings example embodiments, butthe subject matter is not limited to the specific elements andinstrumentalities disclosed.

FIG. 1 is a side view of a simple guidance package for the ameliorationof the damage and pain caused by bruxism in accordance with an exampleembodiment.

FIG. 2A is an overhead view of the internal topography of a maxillaryguidance component of a guidance package in accordance with an exampleembodiment.

FIG. 2B is an enlarged cross-sectional view of a maxillary guidancecomponent of a simple guidance package along line A-A′ of FIG. 2A inaccordance with an example embodiment.

FIG. 2C is an enlarged cross-sectional view of a maxillary guidancecomponent of a simple guidance package along line B-B′ of FIG. 2A inaccordance with an example embodiment.

FIG. 3 is a perspective view of a mandibular guidance component of asimple guidance package in accordance with an example embodiment.

FIG. 4 is a transparent view of a simple guidance package positionedwhen the mandible is in a centric relation hinge axis at appropriatevertical dimension position in accordance with an example embodiment.

FIG. 5 is a perspective view of a virtual or physical retentive piececonfigured to receive a guidance package in accordance with an exampleembodiment.

FIG. 6 is a schematic drawing showing an example method for usingretentive pieces as platforms and attachment points for a guidancepackage for both the maxillary and mandibular arches.

FIG. 7 is a schematic drawing showing an example method for usingretentive pieces for a patient with a significant Class II malocclusion.

FIG. 8 is a schematic drawing showing an example method for usingspecial retentive pieces for a patient with a significant Class IIImalocclusion.

FIG. 9 is a planar perspective view of a “canine guidance” guidancepackage for a patient with bruxism in accordance with an exampleembodiment.

FIG. 10 is a planar perspective view of a “group function” guidancepackage for a patient with bruxism or other condition in accordance withan example embodiment.

FIG. 11A is a planar perspective view of a “bilateral anteriorrepositioning” guidance package for a patient with TMD or a sleep apneapatient in accordance with an example embodiment.

FIG. 11B is a schematic drawing of indexing the mandible left laterallyto the maxilla in accordance with an example embodiment.

FIG. 11C is a schematic drawing of indexing the mandible right laterallyto the maxilla in accordance with an example embodiment.

FIG. 12A is a planar perspective view of an “asymmetric protrusive”guidance package for a patient who has a damaged disc within the leftTMJ in accordance with an example embodiment.

FIG. 12B is a planar perspective view of a “asymmetric protrusive”guidance package for a patient who has a damaged disc within the rightTMJ in accordance with an example embodiment.

FIG. 13A is a planar perspective view of an “asymmetric” guidancepackage for a patient who has a damaged structure on the right side ofthe mandible in accordance with an example embodiment.

FIG. 13B is a planar perspective view of an “asymmetric” guidancepackage for a patient who has a damaged structure on the left side ofthe mandible in accordance with an example embodiment.

FIG. 14 is a perspective view of a Jaw Motion Analyzer for collectingTMJ and range of motion data from a patient and visualization of jawmovement of a patient in real time in accordance with an exampleembodiment.

FIG. 15 depicts a virtual articulator when virtual models of a patient'steeth are set up based on the input data from a patient, who has a ClassI occlusion, and have the virtual retentive pieces in place inaccordance with an example embodiment.

FIG. 16 is a conceptual drawing of the relative position of a guidancepackage (on a maxillary occlusal plane mid-sagittally) to the maxillaryteeth set up in the virtual environment of a virtual articulator inaccordance with an example embodiment.

FIG. 17 is a virtual side view of the virtual guidance package placedrelative to the virtual retentive pieces according to the relativeposition in FIG. 16 in the virtual environment of a virtual articulatorin accordance with an example embodiment.

FIG. 18 is a perspective view of a completed CAD-CAM guidance packagederived appliance for a patient without a severe malocclusion, Class I,from the inside of the mouth, in accordance with an example embodiment.

FIG. 19 is a perspective view of a completed CAD-CAM guidance packagederived appliance for a patient with a Class II malocclusion from theinside of the mouth, in accordance with an example embodiment.

FIG. 20 is a perspective view of a completed CAD-CAM guidance packagederived appliance for a sleep apnea patient or a patient with a ClassIII malocclusion from the inside of the mouth, in accordance with anexample embodiment.

FIG. 21 is a schematic side view of a finished CAD-CAM guidance packagederived appliance for a bruxism or TMD patient without a severemalocclusion, Class I, in accordance with an example embodiment.

FIG. 22 is a schematic side view of a finished CAD-CAM guidance packagederived appliance for a bruxism or TMD patient with a Class IImalocclusion, guidance package derived appliance in accordance with anexample embodiment.

FIG. 23 is a schematic side view of a finished CAD-CAM guidance packagederived appliance for a bruxism or TMD patient with a Class IIImalocclusion, or a sleep apnea guidance package derived appliance inaccordance with an example embodiment.

FIG. 24A is a conceptual drawing of the relative position of themaxillary and mandibular retentive pieces and virtual point(s) along thetransverse plane for a bruxism or TMD patient without a severemalocclusion, Class I, in accordance with an example embodiment.

FIG. 24B is a conceptual drawing of the relative position of themaxillary and mandibular retentive pieces and virtual point(s) along thetransverse plane for a bruxism or TMD patient with a Class IImalocclusion, in accordance with an example embodiment.

FIG. 24C is a conceptual drawing of the relative position of themaxillary and mandibular retentive pieces and virtual point(s) along thetransverse plane for a bruxism TMD patient with a Class IIImalocclusion, or a sleep apnea patient in accordance with an exampleembodiment.

FIG. 25 is a conceptual drawing of potential positions of a singlevirtual point along the transverse plane between the maxillary andmandibular retentive pieces for a bruxism or TMD patient without asevere malocclusion, Class I, in accordance with an example embodiment.

FIG. 26 is a conceptual drawing of potential positions of a pair ofvirtual points along the transverse plane between the maxillary andmandibular retentive pieces for a bruxism or TMD patient without asevere malocclusion, Class I, in accordance with an example embodiment.FIG. 27 is a conceptual drawing of potential positions of a singlevirtual point inside a virtual envelope bordered transversely,sagittally, and vertically by the 3D criterion for selecting thatvirtual point.

FIG. 28 is a flowchart for a method for preparing a guidance packageequipped appliance for a patient with one or more of bruxism, TMD, andsleep apnea, in accordance with an example embodiment.

FIG. 29 illustrates example arch types that may be accommodated with aguidance package according to some example embodiments.

FIGS. 30A and 30B illustrate virtual retentive pieces being applied tovirtual arches according to some example embodiments.

FIGS. 31A-31E illustrate virtual patient arches that feature virtualplanar curves for 3D region calculation according to some exampleembodiments.

FIG. 32 is a flowchart of a method of developing a guidance solutionaccording to an example embodiment.

FIG. 33 illustrates developing of a guidance package according to anexample embodiment.

FIG. 34 illustrates guidance packages according to some exampleembodiments.

FIGS. 35A-35G illustrate patient solutions developed according tocertain example embodiments.

FIGS. 36A-42 illustrate different solutions from example guidancepackages according to some example embodiments.

FIG. 43A illustrates an example maxillary arch before and aftermodification using a guidance package derived restorative guideaccording to an example embodiment.

FIG. 43B illustrates two parametric restorative choices derived from acanonical canine guidance package that have corollary restorative guidesto modify the opposing arch according to some example embodiments.

FIG. 44A illustrates the curve of Spee.

FIG. 44B illustrates the curve of Wilson.

FIG. 44C illustrates the sphere of Monson.

FIGS. 45A-45D illustrate development, selection, and implementation of aguidance solution according to an example embodiment.

DETAILED DESCRIPTION

To facilitate an understanding of the principles and features of thepresent disclosure, various illustrative embodiments are describedbelow. To simplify and clarify explanation, the example embodiments aredescribed below as applied to guidance packages and oral retentionpieces including guidance packages for obtaining a desired movementprofile for a recipient's, e.g., a patient's, mandibular arch inrelation to the maxillary arch. In some cases, the guidance packages ororal retention pieces may be used for, as non-limiting examples,treating a patient with bruxism, TMD, sleep apnea, or treating a patientthat needs full mouth reconstruction or optimization, due to dentalcaries, periodontal disease, edentulism, or other medical and/or dentalissues.

The components, steps, and materials described hereinafter as making upvarious elements of example embodiments are intended to be illustrativeand not restrictive. Many suitable components, steps, and materials thatwould perform the same or similar functions as the components, steps,and materials described herein are intended to be embraced within thescope of the invention. Such other components, steps, and materials notdescribed herein can include, but are not limited to, similar componentsor steps that are developed after development of the invention.

As discussed above, medical practitioners, such as dentists, haveroutinely used many devices and prosthetics in an attempt to obtain adesired movement and stop profile, perhaps to a new index position ofthe mandible in relation to the maxilla, for a patient mandible inrelation to the maxilla, such as to correct for bruxism, sleep apnea,TMD, patient reconstruction, rehabilitation, restoration oroptimization. However, conventional systems are inefficient incustomizing these devices for particular patients.

Accordingly, some example embodiments make the use of virtualarticulators that allow devices to be designed and customized in avirtual environment prior to the creation of the physical device to beused by a patient. For example, various embodiments provide systems andmethods for employing a virtual articulator to design and produceretention pieces having a guidance package to provide a desired movementprofile for a patient, often to a new index position of the mandiblerelative to the maxilla. Various embodiments can use different virtualarticulators known in the art, such as Exocad and 3 Shape, orarticulators later developed.

According to an example embodiment, there is provided a method forproducing one or more retention pieces having a guidance package toprovide a desired movement profile for a recipient, such as a patient.The method includes obtaining data descriptive of (1) mandibular andmaxillary arches of a patient, (2) an index position of the mandibulararch with respect to the maxillary arch of the patient at apredetermined (prescribed) maximum closure position, (3) at least onetemporomandibular joint, and (4) range of motion data for the mandibleof the patient. The data descriptive of the mandibular and maxillaryarches can be obtained a number of ways known in the art. In someembodiments, the data can result from imaging of maxillary andmandibular impressions or models from a patient. In some embodiments,the data can result from direct scanning systems. Examples of directscanning systems include, but are not limited to, Planmeca/E4D Planscan,3 shape Trios, and Cadent Itero. In some embodiments, the data canresult from imaging, e.g., x-ray, of a patient's mandible and maxilla.In some embodiments, the data can result from systems that combine 3Dx-ray with scanning, including, but not limited to, the Planmeca system.In some embodiments of the present disclosure, the data descriptive ofthe mandibular and maxillary arches can be used to create a visualrepresentation of the patient's mandibular and maxillary arches within avirtual articulator.

The data descriptive of an index position of the mandibular arch withrespect to the maxillary arch of the patient at a predetermined(prescribed) maximum closure position can also be obtained in a numberof ways. In some embodiments, the data can result from measurementstaken by an examiner, e.g., a dentist, when examining a patient. In someembodiments, the dentist may use other means to determine theappropriate index position such as 3D radiography, the combination(fusion) of 3D radiography and scanning (Planmeca), and a Jaw MotionAnalyzer.

The data descriptive of the at least one temporomandibular joint (TMJ),and mandibular range of motion data can also be obtained in manydifferent ways and can include many different pieces of information. Insome embodiments, the TMJ and range of motion data can be unique to aparticular patient. In some embodiments, the TMJ and mandibular range ofmotion data can be generic TMJ and range of motion data to a class ofpeople, e.g., taken based on average measurements from a number ofpeople. In some embodiments, the TMJ and mandibular range of motion datacan be indicative of how the TMJ hinges, slides, and/or rotates andfurther is indicative of the movement and envelope of function of themandible. This data may be collected by a Jaw Motion Analyzer such asZebris or Planmeca 4D, or by other methods.

In certain embodiments, the method further includes modeling movement ofvirtual representations of the mandibular arch in relation to themaxillary arch of the patient within a virtual articulator based atleast in part on at least a portion of the data. As discussed above, thedata can be used to create virtual representations of the mandibular andmaxillary arches of a patient. Additionally, based on the TMJ data andindex data, the virtual articulator can be used to model how aparticular patient's mandible moves relative to their maxilla, which canbe helpful to visualize locations where grinding of teeth occur in avirtual environment. By modeling the movement, it can be determined howthat movement might be altered to obtain a desired effect, i.e., adesired movement profile.

In some embodiments, the method further includes specifying anappropriate guidance package based at least on a desired movementprofile for the mandible relative to the maxilla. The guidance package(canonical movement and stop profile) can be a virtual representationand/or a mathematical object. In some embodiments, the appropriateguidance package is specified based on at least a portion of the data(or information indicated/represented by the data) and a desiredmovement profile. Various embodiments of the present disclosure can makeuse of many different guidance packages based on many different desiredmovement profiles for a patient, some of which are discussed below.

Accordingly, in some embodiments, the appropriate guidance package canbe specified from a plurality of guidance packages, each preprogrammedto provide a different movement profile. A preprogrammed guidancepackage may be “preprogrammed” in that the relative movement when theguidance components are in contact may be determined beforehand. Forexample, a guidance package may include a mandibular guidance componentand a maxillary guidance component configured to mate with one another.When the guidance components are positioned on respective retentivepieces in a correct orientation, the guidance components mayappropriately guide in the “preprogrammed” way a movement of theretentive pieces (and therefore the mandible) as the guidance componentscome together and/or function together in a vertical, protrusive, and/orlateral movement of the retentive pieces (therefore the mandiblerelative to the maxilla) when the guidance components are in contact.

As non-limiting examples, one guidance package (or class of guidancepackages, e.g., canine guidance and/or a group function guidance) may beuseful for obtaining a desired movement profile for a patient sufferingfrom bruxism while a different guidance package (or a different class ofguidance packages, e.g., a bilateral anterior repositioning guidancepackage) may be useful for obtaining a desired movement profile for apatient suffering from sleep apnea. In the case of TMJ dysfunction(“TMD”), within the range of motion of the plurality of the TMJs, theremight be preexisting damage or disease to one or both of the TMJs. Aguidance package (e.g., canine guidance package, group function guidancepackage, asymmetric guidance package, bilateral anterior repositioningguidance package, or a asymmetric protrusive guidance package) couldarrange guidance in many therapeutic strategies, for example, to avoidthe area of damage or to provide gradual step therapy of the damagedarea by a sequence of TMD appropriate guidance package derivedtherapeutic appliances. In the case of a patient rehabilitation, anideal movement guidance package (e.g., a canine guidance package or agroup function guidance package) may be useful to aid in the patientsurgical, restorative, and implant placement management (by providingsurgical, implant placement, and/or restorative guide[s]), and also todesign and produce a solution (e.g., restoration or appliance) forreconstruction, rehabilitation, restoration, or optimization.Accordingly, the present disclosure allows for a user to specify anappropriate guidance package, e.g., a canine guidance package, to beused for a particular patient to achieve the desired movement and stopprofile for that patient.

In some embodiments of the present disclosure, the method furtherincludes selecting one or more virtual points to facilitate placementand orientation of the guidance package in virtual space inside thevirtual articulator. In some implementations, the one or more virtualpoints may correspond to a position and orientation of the guidancepackage with regards to mandibular and maxillary retentive pieces.

In some embodiments, the method further includes positioning a virtualrepresentation of at least one retention piece including the specifiedguidance package about the virtual representations of the mandibular andmaxillary arches within the virtual articulator at a position specifiedto achieve the desired movement profile. For example, if a userspecifies a guidance package to correct for bruxism, the user could usea virtual articulator to place a virtual representation of one or moreretention pieces around the virtual representations of the mandibularand maxillary arches. The one or more retention pieces may include amandibular retention piece for interfacing with the mandibular arch (ora portion thereof) of a user and a maxillary retention piece forinterfacing with the maxillary arch (or a portion thereof) of the user.Each of the one or more retention pieces may include at least a portionof the specified guidance package at a specified location (e.g., at avirtual point) about the mandibular and/or maxillary arches of the userto achieve the desired movement profile that would ameliorate thenegative effects of the user grinding his or her teeth.

For example, a mandibular retention piece can include a portion of aguidance package defined by a convex protrusion, and a maxillaryretention piece can include a portion of the guidance package defined bya concave indention positioned to interface with the convex protrusion.

The one or more retention pieces (or the location of the guidancepackage on the one or more retention pieces) can be positioned at manydifferent locations depending at least in part on the desired movementprofile (and may also depend at least in part on the nature of themandibular and/or maxillary arches). For example, a retentive piece on agiven arch may involve only space on the guidance side of the retentivepiece or may involve tissue that may or may not be modified on theguidance side of the retentive piece. The guidance package including theguidance and stops can be positioned at many different locations on theretentive pieces. For example, the guidance package (e.g., the presetguidance package, the customized with patient data guidance package, aparameterized guidance package, or the various components of guidanceand stops that make up the guidance package) could be positioned at ananterior side of the arches, at a lateral side of the arches, or atlocations between the arches, i.e., where the mandibular and maxillaryarches interface and contact each other.

In some embodiments, the method can further include selecting atransverse, sagittal and/or frontal size for the specified guidancepackage based at least in part on at least a portion of the data. Forexample, based on the data that allows the virtual representation ofmandibular and maxillary arches to be created, a user can determine theappropriate sizing of the guidance package necessary to achieve thedesired movement profile.

In some embodiments, the method can further include modeling relativemovement of the virtual representations of the mandibular and maxillaryarches within a virtual articulator to ensure the desired movementprofile is achieved, the relative movement resulting from the guidanceprovided by the virtual and/or mathematical representation of thespecified guidance package. This can allow the user to verify that thespecified guidance package, selected location, size, and/or modificationof the guidance package will provide the desired movement profile forthe patient when a guidance solution is implemented.

In some embodiments, after modeling the relative movement of the archesthe user may determine that additional adjustments should be made, forexample, as to which guidance package should be specified, the locationat which that guidance package should be placed, the size of thespecified guidance package, and/or a modification of the guidancepackage. The user can then make any changes using the virtualarticulator and model the relative movement that results from thoseadjustments. This process can be repeated until the user, e.g., dentist,is satisfied with the movement profile produced by the guidance package.

In some embodiments, the method can further include a parameterizationof the retentive piece(s) and/or by parameterization of the customizedmovement profile whose boundary is an envelope region (limited or global3D space) and selection of different synergistically shaped guidancepackages.

In some embodiments, the method can further include generating data thatcan be used for CAM to create one or more physical retention piecescontaining the specified guidance package to achieve the desiredmovement profile. In certain embodiments, the method further includesusing CAM to create the physical retention piece(s). Various exampleembodiments of the present disclosure allow the data generated to bestored locally such that the user can use a local CAM system to createone or more retention pieces for the patient. Additionally, variousexample embodiments may allow the generated data to be sent to a remotelocation for the physical retention piece(s) to be printed.

Various embodiments of the present disclosure can make use of manydifferent retention pieces which can include the guidance packages usedto provide the desired movement. For example, in some embodiments, theretention piece(s) can take the form of one or more trays to interfacewith the mandibular and maxillary arches of the patient. In someembodiments, the retention piece includes a denture or a partial dentureincluding all or a subset of the guidance package. In some embodiments,the retention piece includes a crown including a subset of the guidancepackage. In some embodiments of the present disclosure, the retentionpiece includes a bridge including all or a subset of the guidancepackage. In some embodiments of the present disclosure, the retentionpiece includes other fixed or removable prosthetic components includingall or a subset of the guidance package. In some embodiments of thepresent disclosure, the retention piece includes a bruxism appliance, asleep apnea appliance, a TMD appliance, or other therapeutic,restorative, or protective appliance including all or a subset of theguidance package.

Various embodiments of the present disclosure can also make use of manydifferent guidance packages, including, but not limited to thoseguidance packages described in U.S. patent application Ser. Nos.13/573,283, 13/774,033, 13/774,920, 13/918,754, 14/083,467, and14/748,805, as would be understood by one of ordinary skill.

In an example embodiment of the present disclosure, the guidance packageincludes at least one protrusion extending away from the retentionpiece(s), the protrusion having a geometrical shape that causes themandibular arch relative to the maxillary arch to move in the desiredmovement profile when the protrusion mechanically contacts a surface ofthe other of the mandibular and maxillary arches (or a surface of theguidance package interfacing with the other of the mandibular andmaxillary arches). In some implementations, the guidance package may bea virtual representation and/or a mathematical object.

In addition to methods, the present disclosure also provides systems forproducing a retention piece or pieces having a guidance package tocorrect a movement profile of a patient. In an example embodiment of thepresent disclosure, the system includes at least one processor and atleast one memory. In accordance with various embodiments of the presentdisclosure, the at least one memory can store instructions that, whenexecuted by the processor, cause the system to perform and/or allow auser to perform one or more of the various method steps discussed above.

For example, in some embodiments of the present disclosure, the memoryincludes instructions that, when executed by the processor, cause thesystem to: obtain data descriptive of (1) mandibular and maxillaryarches of a patient, (2) an index position of the mandibular arch withrespect to the maxillary arch of the patient at a predetermined(prescribed) maximum closure position, and (3) the TMJs; enable modelingof movement of virtual representations of the maxillary and mandibulararches of the patient on a virtual articulator based at least in part onat least a portion of the data (e.g., by an operator); provide selectionof a guidance package based at least on a portion of the data and adesired movement profile for the mandibular arch relative to themaxillary arch; allow an operator to customize the movement profile(e.g., with patient specific, average, generic, or other data); allow anoperator to determine one or more virtual points for placement andorientation of retentive pieces and the specified guidance package;allow an operator of the system to position a virtual representation ofthe retention pieces including the specified or customized guidancepackage about the virtual representations of the mandibular andmaxillary arches on the virtual articulator at a position specified toachieve the desired movement profile; allow an operator of the system tomodel determined movement of the virtual representations of themaxillary and mandibular arches on the virtual articulator to ensure thedesired movement profile is achieved, the determined movement resultingfrom guidance provided by the virtual representation of the specifiedand customized guidance package; and generate data that can be used inCAM to create a physical retention piece or physical retentive piecescontaining both the parameterized retentive piece(s) and the sized,indexed, adjusted, attached and parameterized respective components ofthe specified guidance package to achieve the desired movement profile.In some cases, the instructions, when executed by the processor, mayfurther cause the system to parameterize the retentive piece(s) and/orthe movement profile specification with a boundary of a global enveloperegion (3D region) or multiple 3D regions and different synergisticallyshaped guidance packages.

In some embodiments of the present disclosure, the memory furtherincludes instructions that, when executed by the processor, cause thesystem to use CAM to create the physical retention piece.

In some embodiments of the present disclosure, the memory furtherincludes instructions that, when executed by the processor, cause thesystem to allow an operator of the system to select a transverse,sagittal and/or frontal size for the specified guidance package based atleast in part on at least a portion of the data.

In some embodiments, it may be important to understand the shape of thevolume of space between the mandibular and maxillary arches of aparticular individual (e.g., patient). The combination of hinge andsliding motions makes the TMJ arguably among the more complex joints inthe body. For a particular patient, the plurality of movement of bothTMJs completely defines the range of motion of a mandible, until therange of motion is influenced by the interferences and guidance of teethor prosthetics or appliances, which occurs as the mandible closes andcontact is made between the opposing arches. As the mandible closes,within the range of motion of the TMJs, the first contact is madebetween the mandibular arch and the maxillary arch. From first contactuntil maximum closure are pathways that are defined by the interferencesand guidance of both arches (e.g., teeth, other tissue, existingprosthetics, and/or appliances of the patient).

For many reasons in dentistry, medicine, and elsewhere it is desirableto affect change in providing a different maximum closure position ofthe mandible in relation to the maxilla and to provide prescribedpathways (a therapeutic, corrective, preventive, or protective movementprofile) to move the mandible to that prescribed position. Some examplesof these could include bruxism appliances, sleep apnea appliances, andTMD appliances. Other examples include a patient optimizing,rehabilitating, reconstructing or restoring by establishing a positionof maximum closure and a guidance profile to that position as themandible closes through selection by a clinician for that patients'mandible as intended by the clinician.

Embodiments of the present disclosure provide a way to apply (e.g.,virtually attach) a sized, indexed, and adjusted guidance package to oneor more retentive pieces to achieve a prescribed guidance profile for aspecific patient. Afterwards, an appliance could be manufactured (e.g.,printed using 3-D printing) having the applied guidance package.

Unfortunately, the position of the guidance package on the retentivepiece(s) may be in conflict with some other consideration for therecipient, or the clinician has a specific end product like an implantretained denture, in which, although the guidance package system hasprovided the appropriate guidance profile to the prescribed maximumclosure position, the topography and contact areas of that appliance orrestoration must be different. These other considerations may guide aselection of potential solutions or limit a universe of acceptablesolutions. For example, if a sleep apnea patient feels anxious aboutanteriorly placed guidance (e.g., in front of the front teeth),parameterization may be used to place the guidance on the posteriorlateral aspects of the retentive pieces to achieve no interference withbreathing as perceived by the patient. As another example, when creatingone or more restorations with “prosthetic teeth” and implant retaineddentures, it may be desirable to implement all guidance functionalitywith the shapes and inclinations of the prosthetic teeth so that aseparate guidance package (e.g., retention piece) is not required.

The total working space for retentive pieces, guidance packages, and allother functions of the guidance package system is referred to as aglobal 3D region. Alternatively, multiple 3D regions may be defined forguidance package system calculations and modifications. The spacebetween (or including) the mandibular retentive piece and the maxillaryretentive piece at the prescribed maximum closure position of themandible in relation to the maxilla has a geometric shape of an archform that comports to that patients' skeletal frame of maxilla andmandible. It is further understood that within that total area andvolume of that space (a 3D region that may be in a shape of a hyperbolicparaboloid) exists both the maxillary and mandibular guidance portions(that attach to their respective retentive pieces). Within this spacethe two interacting guidance pieces may be in contact but may not beconnected. Those contact areas may involve the entire arch form of oneor both arches, or only portions thereof.

Using various embodiments of the present disclosure, a desired guidanceprofile from first contact to maximum closure can be established withina virtual environment using a virtual articulator. The guidance profileprovided by the interacting shapes upon closure of the mandible to themaximum closure position (or index position) in the context of range ofmotion of the plurality of the TMJs defines a region of space, and assuch, may be considered a mathematical or virtual object that isamenable to parametrical representation achieving an arbitrary degree ofprecision in its approximation of this intrinsic object. Byparameterizing the space between the maxillary and mandibular retentivepieces, an envelope (3D region) within which the areas, volumes, and thetopography of the contact surfaces of the guidance and stop componentscan now be changed in concert with each other in a way that maintainsthe determined movement profile of the indexed, sized, adjusted andattached guidance package. The space between the retentive pieces may beconsidered a limited 3D region used for parameterization of the guidancepackage solutions. The space that includes room for parameterizingretentive piece(s), the guidance package solution, and other functionsof the guidance package system may be considered a global 3D region. Indifferent embodiments, these parameterizations may occur in varioussequential or overlapping orders or simultaneously.

Various embodiments of the present disclosure allow for the productionof many different retentive pieces, which can be used by a user/patientto obtain a desired movement profile. In some embodiments, the retentivepiece(s) can be fixed or removable appliances such as bruxism, sleepapnea, and TMD appliances. In some embodiments, the retentive piece(s)can be a complete arch of fixed prosthetics like crowns and bridgesmounted on teeth and/or implants. In some embodiments, the retentivepiece(s) can be a removable appliance like a tooth or implant borneremovable partial denture, or complete denture. In some embodiments, theretentive piece(s) can be a combination of any of the above prostheticor patient features or modified patient features that reflect the fullarch mechanics of the present disclosure system. In some embodiments,restorative, surgical, and implant placement guides may be derived fromthe guidance package system.

Certain embodiments discussed herein refer to placing a patient's jawsin a predetermined index position (e.g., a prescribed maximum closureposition), such as centric relation (CR). It is to be understood that,while CR is a relaxed position for many bruxism patients, apredetermined index position (e.g., prescribed maximum closure position)may also refer to other relaxed positions such as a position chosenand/or refined by muscle testing or a relaxed position chosen by thedental professional using 3D radiography, MM, sonography, other imaging,or a Jaw Motion Analyzer. Further, it should be understood that thepredetermined index position may also refer to a position that is notnecessarily relaxed but is, for example, otherwise chosen for itstherapeutic value, including, but not limited to, a position selected bythe dental/medical professional based on the damage or disease profileof the patient, a position selected by the dental/medical professionalthat adequately moves the mandible protrusively to address sleep apnea,and a therapeutic position selected by the dental professional using 3Dradiography, MRI, sonography, other imaging, and/or a Jaw MotionAnalyzer.

One or more virtual points may be generated based on one or more of theindex position and one of the retentive pieces. A virtual guidancepackage may be positioned in virtual space based on the one or morevirtual points. For example, in one embodiment, the virtual guidancepackage may be positioned based on a single virtual point without theneed for orientation, alignment, or position data of either virtualretentive piece. In this fashion, the virtual guidance package may be astock (e.g., preformed or pre-programmed) guidance package that iscustomized after it is positioned or a customized guidance package.

In another embodiment, the virtual guidance package may be positionedbased on a single virtual point along with one or more of orientation,alignment, and position data of at least one of the virtual retentivepieces. The orientation, alignment, and/or position data of the virtualretentive piece(s) provide context for relative positioning of thevirtual point in virtual 3D space. In this fashion, the virtual guidancepackage may be a stock guidance package that does not requirecustomization, or a virtual guidance package that may require a reducedcustomization effort which may decrease the time and cost associatedwith producing the guidance package derived product for a particularpatient.

In another embodiment, the virtual guidance package may be positionedbased on three or more virtual points, which collectively providecontext for relative positioning of the guidance package in threedimensions without requiring orientation, alignment, or position of thevirtual retentive pieces. In this fashion, the virtual guidance packagemay be a stock guidance package that does not require customization, ormay reduce the customization effort, which may decrease the time andcost associated with producing the guidance package derived product fora particular patient.

The guidance package may include a virtual maxillary guidance componentand a virtual mandibular guidance component. After positioning theguidance package in virtual space, the virtual maxillary guidancecomponent may be connected to the virtual maxillary retentive piece toform a first part of a virtual guidance package equipped appliance.Similarly, the virtual mandibular guidance component may be connected tothe virtual mandibular retentive piece to form a second part of thevirtual guidance package equipped appliance. The virtual maxillaryguidance component and the virtual maxillary guidance component may bepre-oriented towards one another in a correct orientation. The correctorientation may be maintained until the virtual guidance components areconnected to the respective virtual retentive pieces. Guidance packageequipped appliance production data based on the first and second partsof the virtual guidance package equipped appliance can then betransmitted. For example, the guidance package equipped applianceproduction data may be transmitted to a manufacturer equipped with oneor more of CAM, CNC technology, an in-office 3D printer, mill, and otheradditive and/or reductive CAM production device(s).

In other embodiments, generating the one or more virtual points mayinclude positioning the one or more virtual points to provide athreshold clearance (e.g., 1 mm or more) between the virtual maxillaryretentive piece and the virtual mandibular retentive piece.

In some embodiments, the method may also include virtually simulatingmovement of the virtual guidance package equipped appliance. Forexample, in some embodiments, movement of a stock guidance package maybe simulated to help determine which stock guidance package is mostappropriate for a particular patient for a particular purpose, and/orwhether customization of the selected stock guidance package isrequired. If a guidance package is customized, the movement of thecustomized guidance package may be simulated to confirm that it willoperate as intended and, if necessary, indicate a need for furthercustomization prior to producing a physical guidance package derivedappliance. This can help decrease time and cost associated withproducing the customized guidance package for a particular patient, asit avoids multiple iterations of testing movement of a physical guidancepackage derived appliance in a patient's mouth. It may also provideincreased accuracy as the dental practitioner may have improvedvisibility in the virtual model compared to a physical model placedwithin a patient's mouth.

In some embodiments, generating the one or more virtual points mayinclude positioning two virtual points that are bilaterally equidistantfrom a reference plane. The reference plane may be perpendicular to amid-sagittal plane and positioned at a specific distance (in someexamples about 6 mm) from a most anterior aspect of one of the virtualretentive pieces (e.g., the maxillary retentive piece) along an occlusalplane mid-sagittally. Further, connecting one of the virtual guidancecomponents (e.g., the maxillary guidance component) to one of thevirtual retentive pieces (e.g., the maxillary retentive piece) may bebased on the two virtual points and an orientation, alignment, and/orposition of the other virtual retentive piece (e.g., the mandibularretentive piece)

In other embodiments, generating the one or more virtual points mayinclude positioning one virtual point proximate a reference planepositioned at a specific distance (in some examples about 6 mm) from amost anterior aspect of one of the virtual retentive pieces (e.g., themaxillary retentive piece) along an occlusal plane mid-sagittally. Thereference plane may be perpendicular to a mid-sagittal plane. Further,connecting one of the virtual guidance components (e.g., the maxillaryguidance component) to its respective virtual retentive piece (e.g., themaxillary retentive piece) may be based on the virtual point and anorientation, alignment, and/or position of the other virtual retentivepiece (e.g., the mandibular retentive piece). In some embodiments, thevirtual point may be placed 3Dly (e.g., as a 3D vector) so that aguidance package may be used without modification or to minimizemodification. If the virtual point is a 3D vector, the direction mayindicate an orientation of a movement profile and its magnitude mayindicate a scaling of the movement profile.

In some embodiments, obtaining patient data may further includeobtaining TMJ data associated with left and right TMJs of the patient.

Positioning the virtual guidance package in virtual space may includepositioning the virtual guidance package in a guidance package indexposition such that the mandible is adjusted outside of centric relationbased on the virtual point. By adjusting the mandible, the guidancepackage index position may be configured to protrusively, laterally, andvertically recapture the left and right TMJ discs. Further, connectingone of the virtual guidance components (e.g., the maxillary guidancecomponent) to its respective virtual retentive piece (e.g., themaxillary retentive piece) may be based on the guidance package indexposition and an orientation, alignment, and/or position of the othervirtual retentive piece (e.g., the mandibular retentive piece).

In some embodiments, one of the left and right TMJ condyles must travelfurther than the other TMJ condyle for the recapture of its relativedisc.

In other embodiments, obtaining patient data may further includeobtaining TMJ data associated with left and right TMJs of the patient,one of the left and right TMJ discs being anteriorly displaced ordamaged. Generating the one or more virtual points may includeasymmetrically positioning one or more virtual points in relation to amid-sagittal plane proximate a plane perpendicular to the mid-sagittalplane that is positioned at a specific distance (in some examples about6 mm) from a most anterior aspect of one of the virtual retentive pieces(e.g., the maxillary retentive piece) along an occlusal planemid-sagittally. Positioning the virtual guidance package in virtualspace may include positioning the virtual guidance package in a guidancepackage index position such that the mandible is configured to recapturethe damaged TMJ disc based on the one or more virtual points. Further,connecting one of the virtual guidance components (e.g., the maxillaryguidance component) to its respective virtual retentive piece (e.g., themaxillary retentive piece) may be based on the guidance package indexposition and an orientation, alignment, and/or position of the othervirtual retentive piece (e.g., the mandibular retentive piece).

In some embodiments, the guidance package index position may adjust themandible such that it is configured to recapture the damaged TMJ discwhile allowing the other TMJ disc to remain in a centric relationposition, or other rest position.

In other embodiments, obtaining patient data may further includeobtaining damaged structure data associated with the patient. Generatingthe one or more virtual points may include positioning one virtual pointproximate a mid-sagittal plane and proximate a plane perpendicular tothe mid-sagittal plane that is positioned at a specific distance (insome examples about 6 mm) anterior to a most anterior aspect of one ofthe virtual retentive pieces (e.g., the maxillary retentive piece) alongan occlusal plane mid-sagittally. In other embodiments, generating oneor more virtual points may include positioning one or more virtualpoint(s) 3Dly within the frontal, sagittal, and transverse planes.Positioning the virtual guidance package in virtual space may includepositioning the virtual guidance package in a guidance package indexposition configured to treat one or more of a mandible, a TMJ, and astomatognathic condition of the patient based on the damaged structuredata, or a reconstruction due to caries, periodontal disease,edentulism, and/other medical and/or dental reasons. In someembodiments, the guidance package index position may be configured toadjust the mandible out of centric relation. Further, connecting one ofthe virtual guidance components (e.g., the maxillary guidance component)to its respective virtual retentive piece (e.g., the maxillary retentivepiece) may be based on the guidance package index position and anorientation, alignment, and/or position of the other virtual retentivepiece (e.g., the mandibular retentive piece).

In some embodiments, the damaged structure data may indicate that one ofa left side or a right side of a mandible of the patient is damaged.Further, positioning the virtual AGP package in virtual space mayinclude protrusively moving the damaged side of the mandible to advancea condyle of the damaged side out of a centric relation position whileallowing the undamaged side of the mandible to keep a condyle of theundamaged side in the centric relation (or other rest) position.

According to some implementations, instructions for steps or functionsof one or more example embodiments may be stored in data modules. Insome cases, the data modules may be executed by a processor or system toperform a method according to an example embodiment of the presentdisclosure. In some implementations, there may be provided a system thatincludes one or more processors and a memory having software code that,when executed by the one or more processors, is configured to controlthe system to execute functions or methods according to one or moreexample embodiments.

Reference will now be made to the figures, to further describe aspectsof one or more example embodiments. One of ordinary skill willunderstand that the features described with reference to the drawingsare merely examples, and certain implementations may include fewer,additional, or modified elements are anticipated by this disclosure. Insome cases, certain well-known elements may be omitted for compactness.

Referring to FIG. 1 , FIG. 1 illustrates an example guidance packagekit. The guidance package kit 1 of FIG. 1 may include a guidance package4-S. The guidance package 4-S may be a “simple” guidance package (e.g.,a preformed physical guidance package). The simple guidance package 4-Smay be used to ameliorate damage and pain caused by bruxism, or otherpurpose. The guidance package kit 1 could be delivered from themanufacturer, as shown in FIG. 1 , or the guidance package may bealready attached to a retentive piece for one arch (e.g., the maxillaryor mandibular arch) and then indexed onto a retentive piece molded tothe other arch. In some embodiments, the simple guidance package 4-S maybe indexed by a dental professional onto a shelf or shelves of theretentive piece or pieces. The guidance package kit 1 may include amaxillary guidance component 1-1, a mandibular guidance component 1-2,and a holder 1-3 that temporarily holds the two components 1-1 and 1-2together at a desired position. A physical guidance package in any formmay include a maxillary guidance component 1-1, a mandibular guidancecomponent 1-2, and the temporary holder 1-3, and may constitute a simpleguidance package 4-S. As with any guidance package 4 construction, theguidance package 4 may be represented and manipulated virtually and/ormathematically in a virtual environment.

In some embodiments, as with any guidance package 4 construction,steepness 33 and depth 32 of the areas of lateral and protrusiveguidance on the maxillary component 1-1 of the simple guidance package4-S can be controlled or modified to provide anterior stops and guidanceto the mandible for a very wide range of treatment goals that theoperator may have in mind.

FIGS. 2A-2C shows the internal topography of the maxillary guidancecomponent 1-1 of an example simple guidance package 4-S according to anexample embodiment. FIG. 2A is an overhead view of the internaltopography of a maxillary guidance component of a guidance package inaccordance with an example embodiment. FIG. 2B is an enlargedcross-sectional view of a maxillary guidance component of a simpleguidance package along line A-A′ of FIG. 2A in accordance with anexample embodiment. FIG. 2C is an enlarged cross-sectional view of amaxillary guidance component of a simple guidance package along lineB-B′ of FIG. 2A in accordance with an example embodiment. The internaltopography includes a specific guidance of a CR stop 2, a long centric(LC) area 3, a lateral excursion (LE) guidance 5, and a protrusive (P)guidance 6. As shown in FIGS. 2A-2C, the maxillary guidance component1-1 of the simple guidance package 4-S may have a flat area for a stableCR stop 2 extended into a further area of flat for the LC position 3 ofthe mandible extending laterally and anteriorly into blended inclines ofa concave inferiorly oriented shape for LE guidance 5 (FIG. 2C) andprotrusive (P) excursion guidance 6 (FIG. 2B) to provide ideal anteriorguidance to the patient's mandible by the mandibular guidance component1-2 against these features of the maxillary guidance component 1-1 tominimize muscular force and avoid all posterior interferences. Thisfeature of appropriate anterior guidance, which moves the mandibledownward (inferiorly) in its excursions, may allow for a night guard ofsignificantly less vertical dimension at rest than other designs, muchlike an ideal occlusion would. It is contemplated that the maxillaryguidance component 1-1 may take on any size based on a patient's rangeof motion.

FIG. 3 shows the mandibular guidance component 1-2 of the simpleguidance package 4-S kit 1. A base 6-1 of the mandibular guidancecomponent 1-2 may have a superellipse or arch form shape and a samedimension or similar as the maxillary guidance component 1-1, as shownin FIG. 2A.

In some embodiments, the length of the long axis L′ of the oval shapedmandibular guidance component 1-2 may be, including but not limited to,between 15 to 35 mm. The length of the short axis (S′) of the ovalshaped mandibular guidance component 1-2 may be, including but notlimited to, between 8 to 20 mm. A smooth rounded protrusion 7 may bedeveloped on one surface of the mandibular guidance component 1-2. A tipof the protrusion 7 may become engaged in the flat to concave innersurface of the maxillary guidance component 1-1 and guide and limit themovement of a patient's mandible. In some embodiments, the height H′ ofthe smooth protrusion may be, including but not limited to, between I to6 mm. For example, in one embodiment, the height H′ may be about 5 mm.As with any guidance package 4 construction, the steepness and depth ofthe protrusion(s) 7 of the mandibular component 1-2 of the simpleguidance package 4-S can be controlled to provide anterior stops andguidance to the mandible for a wide range of treatment goals the dentalprofessional may have in mind.

FIG. 4 shows the simple guidance package 4-S correlating with the CRposition of the TMJs 9-R and 9-L, which represent the right and leftTMJs, respectively. In some embodiments, as shown, the guidance package4 may replicate ideal anterior guidance. In the context of bruxism, forexample, ideal anterior guidance would provide the patient withimmediate elimination of all posterior interferences by the patient'santerior teeth or, in this example by the guidance components of thesimple AGP, in any excursion of the mandible. A reference point 2represents where the protrusion 7 of the mandibular guidance component1-2 sits at rest in the maxillary guidance component 1-1 when right andleft condyles 8-R and 8-L of the TMJs 9-R and 9-L of the mandible are intheir CR position. As a patient functions or bruxes his mandible, themandibular guidance component 1-2 may provide ideal anterior guidancefor the mandible by means of the mandibular guidance component 1-2functioning against the maxillary guidance component 1-1 in the positionof CR 2, LC 3, LE 5, and P guidance 6. In some embodiments, the guidancepackage 4 may provide ideal anterior guidance without regard to theposition of teeth, the condition of teeth or missing teeth. For example,the guidance package may be indexed and attached to retentive pieceswithin the retentive piece system rather than being attached directly tothe teeth or arch.

FIG. 5 illustrates a retentive piece according to an example embodiment.Retentive piece 10 may facilitate the application of the guidancepackage to a broad spectrum of patients with a wide range of maladies,occlusions and malocclusions. The retentive piece 10 may be disposed onor around the maxilla or mandible, and may have a shelf or protrusion toreceive the appropriate component of the guidance package 4.

Many different retentive pieces can be provided in accordance withvarious embodiments of the present disclosure. FIG. 5 illustrates aretentive piece, in accordance with an example embodiment of the presentdisclosure. The retentive piece may be thin and conform totally orpartially to the anatomy of the patient's arch (maxilla or mandible).The retentive piece 10 includes a tissue side 710 and a guidance side720. The tissue side 710 of the retentive piece is configured to face orcontact tissue of the patient, for example, teeth, bone, gum, and couldbe other prosthetics. The tissue side 710 may totally or partiallyconform to the tissue of the respective arch. The retentive piece may beconnected to the tissue by a variety of mechanisms to include implants,mini implants, prepped or not prepped teeth, other physical features,adhesive, tight fitting compressive plastic, a vacuum, wire, clasps,bonding materials or other attachment mechanism. In some cases, theretentive piece may be formed with a space to accommodate one or more ofthe connection mechanisms.

The guidance side 720 of the retentive piece 10 may be connectable to aguidance and/or stop component. For example, the guidance side 720 mayhave multiple protrusions, shelves, or attachment surfaces in variousshapes and sizes that serve as attachment points and/or platforms forguidance packages or portions of guidance packages. In some embodiments,the guidance side 720 of the retentive piece 10 may have formed thereonguidance and stop features generated by guidance packages of the presentdisclosure. These protrusions and shelves (e.g. 725) may be located onall surfaces of the guidance side 720 of the retentive piece 10 toinclude facial, lingual, and occlusal/incisal. In some embodiments, theretentive piece 10 may be a virtual retentive piece 10. In this case,once a guidance package is selected and an appropriate attachment pointis determined, one or more other protrusions, shelves, or attachmentsurfaces may be removed before the designed retentive piece 10 isphysically created.

With the retentive piece 10, the guidance package 4 equipped appliancemay be suitable for patients who have different types of occlusions andmalocclusions and have bruxism at the same time, or a TMJ disorder,other stomatognathic damage, or a sleep apnea disorder. The guidancepackage appliance may be produced with specific jaw repositioning andguidance limitations as prescribed by the dental professional.

FIG. 6 shows an example application of the retentive piece for both themaxillary and mandibular retentive pieces to enable the guidance packageto be placed anterior to the anterior teeth to include an appliance 13that is a combination of the retentive pieces 10 and a guidance package4. In some embodiments, the guidance package 4 may be attached to theshelf/protrusion 11 via glue 14. In other embodiments, the guidancepackage 4 may be attached to the shelf/protrusion 11 via any chemical ormechanical means. In other embodiments, the virtual guidance package 4may be attached to the virtual shelf/protrusion. As shown, the spacebetween the retentive pieces 10 for the mandible and maxilla isexaggerated to help visualize a first contact point 17 and relativeinterferences (or collisions) of cusps of the teeth. The first contactpoint 17 is the first point of contact between maxillary and mandibularteeth as the patient's jaw is closed into the index position by thedental professional. The application of this appliance to this patientusing anterior guidance and the threshold clearance avoids thisotherwise unwanted point of first contact 17.

In some embodiments, the guidance package 4 may provide anteriorguidance that is not dependent upon teeth. For example, the guidancepackage 4, and therefore the anterior guidance, may be placed anteriorto the most anterior teeth (15 and 21). This configuration may increasethe mechanical advantage of the guidance package 4 over the muscles ofmastication in excursions.

Further, by placing the guidance package 4 further anterior than theactual position of the maxillary anterior teeth and/or the mandibularanterior teeth 15 and/or 21, the guidance package 4 may provide anteriorguidance with minimal vertical dimension 16 increase when the patient'smandible is at rest in CR (or another predetermined indexposition/prescribed maximum closure position). As the guidance package 4can be positioned anterior to both the maxillary anterior teeth 15 andthe mandibular anterior teeth 21, the guidance package 4 can provide 3Danterior guidance displacing the mandible inferiorly in excursions tohelp eliminate interferences (e.g., collisions). Further, as theguidance package 4 and retentive pieces 10 minimize the verticaldimension 16 when the patient is in the predetermined index position(prescribed maximum closure position), the patient's acceptance andcomfort may increase dramatically. Some example methods for finding thefirst contact 17 and the use of a spacer 18 (e.g., a 1 mm sticky butremovable spacer) to identify and create appropriate space in CR (or thepredetermined index position) are described in detail in U.S. PatentApp. Pub. No. 2014/0060549.

FIGS. 7 and 8 illustrate example uses of retentive pieces 10 for apatient who presents with a significant Class II malocclusion and with asignificant Class II malocclusion, respectively.

In FIG. 7 , the retentive pieces 10 are placed on the patient'sretrognathic mandibular arch 20, and on the patient's maxillary arch 22to treat bruxism of a patient with a significant Class II malocclusion.The retentive piece 10 may allow for placement of the guidance package4, and therefore anterior guidance, anterior to the anatomical positionof the mandibular front teeth 21. As shown, the vertical dimension 16 ofthe guidance package derived appliance 13 at rest may be minimized byusing retentive pieces 10. In this configuration, a patient sufferingsignificant Class II malocclusion and bruxism may have a night guardwith much greater mechanical advantage over the muscles of masticationin excursions from CR and may be more comfortable due to minimalvertical dimension 16 increase at rest in CR. Also, a dentalprofessional can provide a proper night guard for a patient who hasthese problems with much less effort.

In FIG. 8 , the retentive pieces 10 are placed on the patient'smaxillary arch 22, and placed on the patient's mandibular arch 20 totreat bruxism of a patient with a significant Class III malocclusion.The retentive piece 10 may allow for placement of the guidance package 4anterior to the anatomical limitation of the maxillary front teeth 15.As shown, the vertical dimension 16 for a patient at rest using theguidance package derived appliance 13 may be minimized due to theflexibility of guidance package placement within and around theretentive piece system. In this configuration, a patient sufferingsignificant Class III malocclusion and bruxism may have a night guardwith much greater mechanical advantage over the muscles of masticationin excursions from CR, and may be more comfortable due to minimalvertical dimension 16 increase at rest in CR. Also, a dentalprofessional can provide a proper night guard for a patient who hasthese problems with much less effort.

In some embodiments, the guidance package 4 may be attached to theopposite retentive pieces 10 (e.g., “upside-down”) and with properrotation of the guidance package 4. In other words, the maxillaryguidance component of the guidance package 1-1 may be attached to amandibular retentive piece and the mandibular guidance component of theguidance package 1-2 may be attached to a maxillary retentive piece,such that the guidance package 4 can be used interchangeably with themaxillary and mandibular retentive pieces.

The guidance package 4 may be configured to provide guidance and limitsto the front end of the mandible 3Dly independent of malocclusion orcondition of the patients' teeth.

The guidance package 4 may be available in different stockconfigurations, which could be modified by the dental professional, andin the context of a CAD-CAM guidance package (a virtual or mathematicalform of the guidance package 4), the guidance package 4 could bedesigned by the dental professional from a template based on diagnosticinformation and a damage profile of a particular patient. Thiscustomizable guidance package 4 may offer a wide range of solutions fortreating patients with bruxism, or TMD, or sleep apnea, and variousocclusions and malocclusions. The guidance package 4 may provide thedental professional with a broad spectrum of 3D patterning to guide thepatient's mandible to the selected destination by a wide range of 3Droutes.

Real human malocclusions can be complex, and are generally classified asClass I, II, or III. These occlusions and malocclusions can be furthercomplicated by anterior and posterior crossbites, overjet, deep bite,open bite and other modifiers and combinations thereof.

In regard to bruxism appliances, a guidance package equipped appliancemay be configured to treat a plethora of different occlusions andmalocclusions, provide anterior guidance to neutralize posteriorinterferences to allow the patient's mandible to function in the beststress bearing position of CR even under the stress of bruxism,eliminate engrams of interferences to decrease inappropriate muscleactivity and spasticity, give protection to the teeth and the TMJ, thereduction of myo-facial pain syndrome, and the reduction of migraineheadaches.

FIG. 9 shows an example design, of a different guidance package 4, a“canine guidance” package 4C (e.g., a bruxism, TMD or otherwiserestorative guidance package). In some embodiments, there may be twoprotrusions 7 a and 7 b on the mandibular component 1-2-C of theguidance package 4-C spaced laterally apart in a way that would mimicideal human “canine” anterior guidance. In other words, the mandibularguidance component 1-2-C of the guidance package 4-C which mimics ideallower canines, may function against the maxillary guidance component1-1-C of the guidance package 4-C, which mimics ideal maxillary teeth ina human exhibiting ideal canine guidance.

This design may be particularly suited for patients whose interferences(e.g., malocclusions) can be more efficiently neutralized by anteriorguidance focused upon lateral poles of the mandibular guidance component1-2-C of the guidance package 4-C, as compared to a single pointedprotrusion 7 of the mandibular guidance component 1-2 of FIG. 3 , when apatient wears the appliance 13 and bruxes.

The maxillary component 1-1-C of the guidance package 4-C may bemodified to provide 3D guidance and limits to the mandible according tocanine guidance when the patient bruxes. The mandibular component 1-2-Cmay be modified to provide 3D guidance and limits to the mandibleaccording to canine guidance when the patient bruxes. In someembodiments, the maxillary component 1-1-C of the guidance package 4-Cmay have a concave inner surface with a cross-sectional shape in ahorizontal plane forming a superellipse or arch form with convex outersides. In other embodiments, the maxillary component 1-1-C may take onany shape configured to mate with the mandibular guidance component1-2-C. The size of the maxillary component 1-1-C may be, for example,less than 50 mm by 50 mm dependent upon the full range of motion andborder limits of the mandible both horizontally and vertically for aparticular patient. In this example embodiment, there are two areas ofCR contact 2 a and 2 b on the posterior aspect of the flat area of themaxillary component 1-1-C with a much broader area of long centric 3′ onthe anterior aspect of the flat area of the maxillary component 1-1-C.The steepness 33 and depth 32, as shown in FIG. 1 , of the areas oflateral and protrusive guidance on the maxillary component 1-1-C of theguidance package 4-C can be controlled or modified to provide anteriorstops and guidance to the mandible for a very wide range of treatmentgoals that the dental professional may have in mind.

In some embodiments, when the patient moves his mandible inlaterotrusion to the left, only the left protrusion 7 b may be incontact. As the patient moves his mandible back to CR, the rightprotrusion 7 a may move back into contact simultaneous with the leftprotrusion 7 b. As the patient moves his mandible in laterotrusion tothe right from CR, only the right protrusion 7 a may be in contact withthe maxillary aspect 1-1-C of the guidance package 4-C.

Within the full range of motion of the TMJs 9R and 9L of the mandible8-1, both protrusions 7 a and 7 b of the mandibular guidance component1-2-C of the guidance package 4-C may be in contact in CR with themaxillary guidance component 1-1-C of the guidance package 4-C at points2 a and 2 b or long centric area 3′, or one or both protrusions 7 a or 7b may be in contact with an inclined plane, lateral guidance 5, whichlocate on the lateral aspects of the inclined plane, or protrusiveguidance 6, which locates on the anterior aspect of the inclined plane,of the maxillary component 1-1-C of the guidance package 4-C to provideappropriate anterior “canine” guidance to avoid posterior interferences,eliminate engrams, reduce the force of the muscles of mastication, andto allow freedom to the condyles 8-R and 8-L of the TMJ's 9-R and 9-L tobe in their best stress bearing positions regardless the patient'sindividual occlusion or malocclusion.

The steepness, depth, and relative locations of the protrusions 7 a and7 b of the mandibular component 1-2-C of the guidance package 4-C can becontrolled to provide anterior stops and guidance to the mandible for avery wide range of treatment goals the dental professional may have inmind.

In some embodiments, the guidance package 4-C may be produced and/orapplied with a minimal vertical dimension 16 penalty, for example, lessthan 5 mm, when the patient is at rest because the elimination ofposterior interferences is accomplished with 3D guidance displacing themandible inferiorly in excursions from CR. An excursion would be amovement of the mandible left, right or protrusively from the hinge axisof CR or long centric.

From the hinge axis of CR, or another point or axis of the dentalprofessional's choosing, the 3D guidance of FIGS. 1, 4, 9, 10, 11A, 12A,12B, 13A and 13B of the guidance packages may provide anterior guidanceand eliminate the interferences of all excursions to the full borderlimits of the mandible. And furthermore, the guidance of the guidancepackage may be placed anterior to the anterior teeth so the physicalmaterial for that guidance (e.g., the guidance package) is not developedon a retentive piece at a position in between maxillary and mandibularanterior teeth, but rather independent of the position of anterior teethand could be anterior (or posterior) to anterior teeth.

The guidance package 4-C can be attached to the retentive pieces up-sidedown and with proper rotation of the guidance package 4-C. In otherwords, the maxillary guidance component of the guidance package 1-1-Ccan be attached to a mandibular retentive piece and the mandibularguidance component of the guidance package 1-2-C is attached to amaxillary retentive piece, such that the guidance package 4-C can beused interchangeably with the maxillary and mandibular retentive pieces.

FIG. 10 provides another example design of a different guidance package4, a “group function” guidance package 4-G (e.g., a bruxism, TMD orotherwise restorative guidance package), that may be created for adifferent version of a bruxism appliance. There may be a very broadprotrusion 7′ on the mandibular guidance component 1-2-G of the guidancecomponent 4-G that would mimic group function from canine to canine, orpremolar to premolar (or other teeth selected by the dentalprofessional) in a way that would mimic ideal human group functionanterior guidance. The broadness of protrusion 7′ can be accentuatedanterior-posteriorly and/or laterally to give freedom to the mandible orset limits to the mandible according to the treatment goals of theoperator. The “group function” guidance package 4-G may be particularlysuited for patients whose particular interferences (e.g., malocclusions)can be more efficiently neutralized by anterior guidance that is broadfrom the left anterior lateral pole to the right anterior lateral poleof the mandibular guidance component of the guidance package 4-G, ascompared to a single pointed protrusion 7 of the mandibular guidancecomponent 1-2 of FIG. 3 , when a patient wears the appliance 13 andbruxes.

The maxillary component 1-1-G of the guidance package 4-G may bemodified according to group function guidance when the patient bruxes.The mandibular component 1-2-G of the guidance package 4-G may bemodified according to group function guidance when the patient bruxes.In some embodiments, the maxillary guidance component 1-1-G of theguidance package 4-G may have a concave inner surface with across-sectional shape in a horizontal plane forming a superellipse orarch form with convex outer sides. In other embodiments, the maxillaryguidance component 1-1-G may take on any shape configured to mate withthe mandibular guidance component 1-2-G. The size of the maxillarycomponent 1-1-G may be, for example, less than 50 mm by 50 mm dependentupon the full range of motion and border limits of the mandible bothhorizontally and vertically for a particular patient.

There may be a broad area of CR stop 2′ that is broader in contrast to aCR stop 2 of a maxillary guidance component that is coupled to a singlepole protrusion 7 and locates on the posterior aspect of the flat areaof the maxillary guidance component, and a broad area of long centric3′, which is broader in contrast to an area of long centric 3 in amaxillary guidance component that is coupled to a single pole protrusion7′ and locates on the anterior aspect of the flat area of the maxillaryguidance component. The steepness 33 and depth 32, as shown in FIG. 1 ,of the areas of lateral and protrusive guidance on the maxillarycomponent 1-1-G of the guidance package 4-G can be controlled ormodified to provide anterior stops and guidance to the mandible for avery wide range of treatment goals that the dental professional may havein mind. Further, the steepness and depth of the protrusion 7′ of themandibular guidance component 1-2-G of the guidance package 4-G can becontrolled to provide anterior stops and guidance to the mandible for avery wide range of treatment goals the dental professional may have inmind.

Within the full range of motion of the TMJ's 9-R and 9-L of the mandible8-1, the broad protrusion 7′ of the mandibular guidance component 1-2-Gof the guidance package 4-G may be in contact in CR 2′ with themaxillary guidance component 1-1-G of the guidance package 4-G or thelong centric area 3′, or a lateral aspect of the broad protrusion 7′ maybe in contact with an inclined plane, lateral guidance 5, which arelocated on both lateral aspects of the inclined plane, or protrusiveguidance 6, which are located on the anterior aspect of the inclinedplane of the maxillary guidance component 1-1-G of the guidance package4-G to provide appropriate anterior “group function” guidance to avoidposterior interferences, eliminate engrams, reduce the force of themuscles of mastication, and to allow freedom to the condyles 8-R and 8-Lof the TMJs 9-R and 9-L to be in their best stress bearing positions.

In some embodiments, the guidance package 4-G may allow for a minimalvertical dimension 16 penalty, for example, less than 5 mm, when thepatient is at rest because the elimination of posterior interferences isaccomplished with 3D guidance displacing the mandible inferiorly inexcursions from CR and long centric. Further, the guidance of theguidance package 4-G may be placed anterior to the teeth so the physicalmaterial for that guidance is not in addition, but independent of andanterior to anterior teeth. This guidance can be provided no matter thecondition or even presence of teeth and because the guidance may beplaced anterior to the traditional limitations of guidance, there isincreased advantage over the muscles of mastication in excursions ascompared to any previous system.

The guidance package 4-G can be attached to the retentive pieces up-sidedown and with proper rotation of the guidance package 4-G. In otherwords, the maxillary aspect of the guidance package 1-1-G can beattached to a mandibular retentive piece and the mandibular aspect ofthe guidance package 1-2-G can be attached to a maxillary retentivepiece, such that the guidance package 4-G can be used interchangeablywith the maxillary and mandibular retentive pieces.

The three example bruxism (some types of TMD and restorative) guidancepackages shown in FIGS. 1, 9 and 10 , may provide a superior bruxismappliance to the vast majority of bruxism patients regardless theirmalocclusion. However, human occlusions and malocclusions are so diverseto each individual that it may not be practical to assign a particularguidance package 4 a particular occlusion or malocclusion or aparticular malady like TMD. Selection of a particular guidance package 4and possibly the modification of that guidance package 4 may require aninformed decision by the dental professional using clinical judgment fora particular situation or a combination of malocclusions and maladies.

In addition to the most common use of the guidance packages 4 shown inFIGS. 1, 9, and 10 , which is the treatment and amelioration of bruxism(some types of TMD, and restorative applications), guidance packages 4of other designs or other guidance and stop profiles may be used tocontrol and limit the mandible 3Dly independent of malocclusion orcondition of the patient's teeth.

Used this way, the guidance package 4 may offer a wide range ofsolutions for other maladies of the mouth, jaws, TMJ, and sleep apnea.When using the guidance package 4, not only does the dental professionalhave 3D control of the mandible, but dependent upon the malady andtreatment prescribed, the guidance package 4 can be indexed in aposition of the mandible in relation to the maxilla of the dentalprofessional's choosing other than CR to greatly expand the scope oftreatments available. In some embodiments, the guidance package 4 may beindexed and attached to retentive pieces within the retentive piecesystem, not directly to teeth or the arch. With the use of a guidancepackage 4, the dental professional has a broad spectrum of 3D patterningavailable to guide the patient's mandible to a selected destination by awide range of 3D routes. Thus, a dental professional may take advantageof a wide range of very different clinical applications of the guidancepackage 4. In some embodiments, the design of a guidance package 4 mayreflect the dental professional's choice and prescription to apply verydifferent guidance and limits to the mandible and/or to each TMJ 9-R and9-L or other variables in the stomatognathic system independently.

In regard to TMD appliances, the goal in all these plethora of differentocclusions and malocclusions in the context of TMD and various otherdamage profiles of the stomatognathic system with or without bruxism, isto provide specialized anterior guidance and limits to treat specificdamage profiles of specific patients and to neutralize posteriorinterferences to eliminate destructive engrams associated withinterferences to decrease muscle activity and spasticity, to giveprotection to the teeth and the TMJ, the reduction of myo-facial painsyndrome, and the reduction of migraine headache. In regard to sleepapnea, the goal is that as the patient closes or is closed to move themandible protrusively, and therefore the tongue forward, to increase thevolume of the airway space.

FIG. 11A shows an example embodiment of a different guidance package 4,a TMD or sleep apnea guidance package, a “bilateral anteriorrepositioning” guidance package 4-TB to enable a dental professional tomake an anterior repositioning appliance to treat bilateral anteriordisc displacement of the TMJs. Again, a very different clinicalapplication of the guidance package 4 and a further example of theflexibility of treatments the guidance package 4 can provide to a dentalprofessional with its ability to provide 3D control of the front end ofthe mandible. To treat bilateral disc displacement of the TMJs, both themandibular guidance component of the guidance package 1-2-TB and amaxillary guidance component of the guidance package 1-1-TB can beindexed so that as the patient closes his mandible 8-1, the mandible canbe guided forward and vertically to the designated position of rest 2″customized to treat the patient's damage in which both the condyles 8-Rand 8-L of the TMJs 9-R and 9-L recapture both the discs bilaterally.

The maxillary guidance component of the guidance package 1-1-TB may havea customized protrusive guidance 6 a located on the posterior aspect ofthe maxillary guidance component 1-1-TB (where otherwise the posterioraspect of the maxillary guidance component 1-1 shown as position 2 and2′ in FIGS. 2 and 10 , respectively of a bruxism guidance package wouldbe to guide the mandible back to CR), to guide the mandible protrusivelyand vertically to this therapeutic position of rest 2″. The position ofrest or predetermined index position (prescribed maximum closureposition) 2″ may be designated or indexed based on the damage of eachpatient.

From this designated position of rest 2″ that has recaptured both discsof the TMJs, the 3D guidance for the mandible to long centric area 3″,on the anterior aspect of the flat area, and then further to lateralguidance 5, and protrusive guidance 6, may provide symmetricalprotection and therapy for the particular damage or malady each patientexhibits, elimination of posterior interferences, elimination ofengrams, and the reduction of the forces of the muscles of masticationin excursions. The lateral guidance 5 may be positioned on both lateralaspects of the inclined plane of the maxillary guidance component. Theprotrusive guidance may be positioned on the anterior aspect of theinclined plane of the maxillary guidance component. The maxillarycomponent 1-1-TB of the guidance package 4-TB may be modified accordingto the therapeutic situation or other considerations. The mandibularcomponent 1-2-TB of the guidance package 4-TB may be modified accordingto the therapeutic situation or other consideration.

In some embodiments, the guidance package 4-TB may provide a minimalvertical dimension 16 penalty when the patient is at rest because theanterior repositioning of the condyles 8-R and 8-L and the eliminationof posterior interferences may be accomplished with 3D guidancedisplacing the mandible 8-1 vertically in the therapeutic movement toreposition the condyles 8-R and 8-L and the excursions from thisdesignated position 2″. Further, the guidance of the guidance package4-TB may be placed anterior to the teeth so the physical material forthat guidance is not in addition, but independent of and anterior toanterior teeth.

This guidance can be provided no matter the condition or even presenceof teeth and because the guidance may be placed anterior to thetraditional limitations of guidance where there is increased advantageover the muscles of mastication in excursions as compared to anyprevious system.

The guidance package 4-TB can be attached to the retentive piecesup-side down and with proper rotation of the guidance package 4-TB. Inother words, the maxillary guidance component of the guidance package1-1-TB can be attached to a mandibular retentive piece and themandibular guidance component 1-2-TB can be attached to a maxillaryretentive piece, such that the guidance package 4-TB can be usedinterchangeably with the maxillary and mandibular retentive pieces.

As with any guidance package 4, a series of guidance package derivedappliances could be designed by the dental professional to gently “walkback” the condyles to CR as the posterior tissues are healed. Forexample, as the condyles heal and become positioned back further, thesame guidance packages (or different guidance packages) can be indexedin a different place to progressively move the condyles. As with anyguidance package construction 4 the steepness, depth, size and shape ofboth guidance components of the guidance package may be modified to meetthe dental professional's goals and/or the damage and malocclusionprofile of a particular patient.

To treat sleep apnea, both the mandibular guidance component of aguidance package 1-2-TB and a maxillary guidance component of theguidance package 1-1-TB can be indexed and/or modified so that as thepatient closes his mandible 8-1, it can be guided forward and verticallyto the designated position of rest (prescribed maximum closure position)2″ customized to move the mandible protrusively to about 50-70% of thatpatient's total protrusive potential. By moving the mandible to theclinically effective protrusive position, the tongue is also movedforward to open the patient's airway to treat the patient's sleep apnea.The maxillary guidance component of the guidance package 1-1-TB may havea customized protrusive guidance component 6 a located on the posterioraspect of the maxillary component (where otherwise the posterior aspectof the maxillary guidance component 1-1, shown as position 2 and 2′ inFIGS. 2 and 10 , respectively, of a bruxism guidance package would be toguide the mandible into centric relation) to guide the mandibleprotrusively and vertically to this therapeutic position of rest 2′ Theposition of rest 2″ may be designated or indexed based on the distancethat the mandible should be moved protrusively to effectively treatsleep apnea of each patient.

From this designated position of rest 2″ that has adequately opened theairway, the 3D guidance for the mandible to long centric area 3″, on theanterior aspect of the flat area, and then further to the lateralguidance 5, and protrusive guidance 6, may provide symmetrical guidance,eliminate posterior interferences, eliminate engrams, and reduce forcesof the muscles of mastication in excursions. The lateral guidance 5 maybe positioned on both lateral aspects of the inclined plane of themaxillary guidance component 1-1-TB. The protrusive guidance 6 may bepositioned on the anterior aspect of the inclined plane of the maxillaryguidance component 1-1-TB. The maxillary component 1-1-TB of theguidance package 4-TB may be modified according to the therapeuticsituation or other consideration. The mandibular component 1-2-TB of theguidance package 4-TB may be modified according to the therapeuticsituation or other consideration.

In some embodiments, the guidance package 4-TB may provide a minimalvertical dimension 16 penalty when the patient is at rest because theanterior repositioning of the mandible and the elimination of posteriorinterferences may be accomplished with 3D guidance displacing themandible 8-1 vertically in the therapeutic movement to anteriorlyreposition the mandible 8-1 for airway opening and the excursions fromthis designated position 2″. Further, the guidance of the guidancepackage 4-TB may be placed anterior to the teeth so the physicalmaterial for that guidance is not in addition to, but independent of andanterior to, the anterior teeth.

This guidance can be provided no matter the condition or even presenceof teeth. Further, as the guidance may be placed anterior to theguidance of existing systems, it can provide increased advantage overthe muscles of mastication in excursions.

In some embodiments, the guidance package 4-TB can be attached to theretentive pieces up-side down with proper rotation of the guidancepackage 4-TB. That is, the maxillary guidance component of the guidancepackage 1-1-TB can be attached to the mandibular retentive piece and themandibular guidance component of the guidance package 1-2-TB can beattached to the maxillary retentive piece such that the guidance package4-TB can be used interchangeably with the maxillary and mandibularretentive pieces.

FIG. 12A shows another example embodiment of a guidance package 4, a TMDtreatment guidance package, an “asymmetric protrusive” guidance package4-TU to enable a dental professional to create a TMD treatment appliancethat can be selective and differential to each TMJ 9-R and 9-L or otherunilateral maladies of the mandible 8-1, or supporting structures.Again, this is another example of a very different clinical application,taking advantage of the robust flexibility of the guidance package 4.

In this example embodiment, the patient has an anteriorly displacedmeniscus in the right TMJ 9-R, and the left TMJ 9-L is normal. Thedental professional may prescribe a guidance package 4TU that anteriorlyrepositions the right condyle 8-R to recapture the displaced meniscus,but allows the left condyle 8-L to be in CR.

On the mandibular aspect of the guidance package 1-2-TU there may be twoprotrusions 7′a and 7′b in which the protrusion on the right 7′a istaller and steeper than the protrusion on the left 7′b. The maxillaryaspect 1-1-TU of the guidance package 4-TU may be modified accordingly.The maxillary component 1-1-TU of the guidance package 4-TU may have aconcave inner surface with a cross-sectional shape in a horizontal planeforming a superellipse or arch form with convex outer sides. In otherembodiments, the maxillary component 1-1-TU may take on any shapeconfigured to mate with the mandibular guidance component 1-2-TU. Thesize of the maxillary component 1-1-TU may be, for example, less than 50mm by 50 mm dependent upon the full range of motion and border limits ofthe mandible both horizontally and vertically for a particular patient.The right area of anterior repositioning 2′a, which recaptures theanteriorly displaced disc of the right TMJ, may be located anteriorlyand have a deeper indentation that is located anteriorly on the rightaspect of the flat area of the maxillary guidance component, and mayhave customized anterior protrusive guidance 6 a, posterior to theprescribed area of rest 2′a in contrast to the position of rest 2′b,which locates on the left posterior aspect of the flat area of themaxillary component, to enable the operator to anteriorly reposition theright condyle 8-R while allowing the left condyle 8-L to assume CR atrest. The maxillary component 1-1-TU of the guidance package 4-TU may bemodified according to the therapeutic situation or other consideration.The mandibular component 1-2-TU of the guidance package 4-TU may bemodified according to the therapeutic situation or other consideration.

In this example embodiment, as the patient closes his mandible 8-1, theright condyle 8-R may be guided anteriorly and vertically by the broaderand taller right protrusion 7′a of the mandibular guidance component1-2-TU of the guidance package 4-TU into the deeper and broader area 2′aof the maxillary guidance component 1-1-TU of the guidance package 4-TUto recapture the displaced disc of the right TMJ 9-R.

The left condyle 8-L of the left TMJ 9-L may be guided into its CR or adifferent designated position by the left protrusion 7′b of themandibular guidance component 1-2-TU of the guidance package 4-TU intothe CR position 2′b of the maxillary guidance component 1-1-TU of theguidance package 4-TU.

From this therapeutically designated position of rest (prescribedmaximum closure position) 2′a and 2′b, based on the patient's damageprofile, which has recaptured the right disc of the right TMJ 9-R, the3D guidance to long centric rest 3′″ and then further to lateralguidance 5, and protrusive guidance 6, may provide asymmetricalprotection and therapy for the particular damage or malady this patientexhibits, elimination of posterior interferences, elimination ofengrams, and the reduction of the forces of the muscles of mastication.

The guidance package 4-TU may provide a minimal vertical dimension 16penalty when the patient is at rest because the anterior repositioningof the right condyle 8-R and the elimination of posterior interferencesis accomplished with 3D guidance displacing the mandible 8-1 verticallyin the therapeutic movement to reposition the right condyle 8-R and theexcursions from this designated therapeutic position. Further, theguidance of the guidance package 4-TU may be placed anterior to theteeth so the physical material for that guidance is not in addition, butindependent of and anterior to anterior teeth. This guidance may beprovided no matter the condition or even presence of teeth and becausethe guidance may be placed anterior to the traditional limitations ofguidance there can be increased advantage over the muscles ofmastication in excursions as compared to any previous system.

The guidance package 4-TU can be attached to the retentive piecesup-side down and with proper rotation of the guidance package 4-TU. Inother words, the maxillary guidance component of the guidance package1-1-TU may be attached to a mandibular retentive piece and themandibular guidance component of the guidance package 1-2-TU may beattached to a maxillary retentive piece, such that the guidance package4-TU can be used interchangeably with the maxillary and mandibularretentive pieces.

FIG. 12B shows the opposite configuration of FIG. 12A, in which thepatient has an anteriorly displaced meniscus in the left TMJ 9-L, andthe right TMJ 9-R is normal. The dental professional may prescribe aguidance package 4-TU that anteriorly repositions the left condyle 8-Lto recapture the displaced meniscus, but allows the right condyle 8-R tobe in CR.

On the mandibular guidance component of the guidance package 1-2-TUthere may be two protrusions 7′a and 7′b in which the protrusion on theleft 7′a is taller and steeper than the protrusion on the right 7′b. Themaxillary guidance component 1-1-TU of the guidance package 4-TU may bemodified accordingly. The maxillary component 1-1-TU of the guidancepackage 4-TU may have a concave inner surface with a cross-sectionalshape in a horizontal plane forming a superellipse or arch form withconvex outer sides. In other embodiments, the maxillary component 1-1-TUmay take on any shape configured to mate with the mandibular guidancecomponent 1-2-TU. The size of the maxillary component 1-1-TU may be, forexample, less than 50 mm by 50 mm dependent upon the full range ofmotion and border limits of the mandible both horizontally andvertically for a particular patient. The left area of anteriorrepositioning 2′a, which recaptures the anteriorly displaced disc of theleft TMJ, may be located anteriorly and have a deeper indentation thanis located anteriorly on the right aspect of the flat area of themaxillary component, and have customized anterior protrusive guidance 6a, posterior to the prescribed area of rest 2′a in contrast to theposition of rest 2′b, which locates on the right posterior aspect of theflat area of the maxillary component, to enable the operator toanteriorly reposition the left condyle 8-L while allowing the rightcondyle 8-R to assume CR or a different designated position at rest.

In this example embodiment, as the patient closes his mandible 8-1, theleft condyle 8L may be guided anteriorly and vertically by the broaderand taller left protrusion 7′a of the mandibular guidance component1-2-TU of the guidance package 4-TU into the deeper and broader area 2′aof the maxillary aspect 1-1-TU of the AGP 4-TU to recapture thedisplaced disc of the left TMJ 9-L.

The right condyle 8-R of the right TMJ 9-R may be guided into its CRposition or a different designated position by the right protrusion 7′bof the mandibular guidance component 1-2-TU of the guidance package 4-TUinto the CR position 2′b of the maxillary guidance component 1-1-TU ofthe guidance package 4-TU.

From this therapeutically designated position of rest 2′a and 2′b, basedon the patient's damage profile, which has recaptured the left disc ofthe left TMJ 9-L, the 3D guidance to long centric rest 3′″ and thenfurther to lateral guidance 5, and protrusive guidance 6, may provideasymmetrical protection and therapy for the particular damage or maladythis patient exhibits, elimination of posterior interferences,elimination of engrams, and the reduction of the forces of the musclesof mastication.

The guidance package 4-TU may provide a minimal vertical dimension 16penalty when the patient is at rest because the anterior repositioningof the left condyle 8-L and the elimination of posterior interferencesis accomplished with 3D guidance displacing the mandible 8-1 verticallyin the therapeutic movement to reposition the left condyle 8-L and theexcursions from this designated therapeutic position. Further, theguidance of the guidance package 4-TU may be placed anterior to theteeth so the physical material for that guidance is not in addition, butindependent of and anterior to anterior teeth. This guidance can beprovided no matter the condition or even presence of teeth and becausethe guidance may be placed anterior to the traditional limitations ofguidance there can be increased advantage over the muscles ofmastication in excursions as compared to any previous system.

The guidance package 4-TU can be attached to the retentive piecesup-side down and with proper rotation of the guidance package 4-TU. Inother words, the maxillary guidance component of the guidance package1-1-TU may be attached to a mandibular retentive piece and themandibular guidance component of the guidance package 1-2-TU may beattached to a maxillary retentive piece, such that the guidance package4-TU can be used interchangeably with the maxillary and mandibularretentive pieces.

FIG. 13A and its mirror image FIG. 13B are two more example embodimentsof a guidance package 4,a TMD treatment guidance package, an“asymmetric” guidance package 4-AT to enable a dental professional totreat a mandible that has had damage to one TMJ, or both TMJs, or themuscles, ligaments, or tendons of mastication unilaterally orbilaterally, or other clinical problems or combinations of clinicalproblems in which the operator needs the ability to control themovements and limits of the mandible in non-traditional 3D pathwayssymmetrically or asymmetrically. This is a very different clinicalapplication of the guidance package 4. The design of this exampleguidance package 4-AT may reflect the dental professional's prescriptionto apply very different guidance and limits to each TMJ 9-R and 9-L orother variables in the stomatognathic system independently.

In this example, the protrusion 7″ may be located laterally to themidline. The asymmetrical depth and steepness of both the mandibularguidance component 1-2-AT and the maxillary guidance component 1-1-AT ofthe guidance package 4-AT can be controlled to provide anterior stops,limits and guidance for the treatment goals of the operator in this caseasymmetrically providing very different parameters to each TMJ 9-R and9-L. In this circumstance the patient's mandible 8-1 upon closing may beguided into a position of rest 2″, which is other than CR that isprescribed by the dental professional for each patient's particularmalady or damage. From this designated position of rest (prescribedmaximum closure position) 2″ the 3D guidance to long centric 3″ whichhas a customized shape, which is designed based on the damage of aspecific patient on the anterior aspect of the flat area of themaxillary component, to provide guidance for this particular damageprofile and then further to lateral guidance 5, and protrusive guidance6, provided asymmetrically in this case, but could also be symmetricalprotection and therapy for the particular damage or malady of a specificpatient. The lateral guidance 5 may be positioned on both lateralaspects of the inclined plane of the maxillary guidance component. Theprotrusive guidance 6 may be positioned on the anterior aspect of theinclined plane of the maxillary guidance component. Both the maxillaryand mandibular components 1-1-AT and 1-2-AT of the guidance package 4-ATmay be modified according to the therapeutic situation or otherconsideration.

The guidance package 4-AT can be attached to the retentive piecesup-side down and with proper rotation of the guidance package 4-AT. Inother words, the maxillary guidance component of the guidance component1-1-AT may be attached to a mandibular retentive piece and themandibular guidance component of the guidance package 1-2-AT may beattached to a maxillary retentive piece, such that the guidance package4-AT can be used interchangeably with the maxillary and mandibularretentive pieces.

CAD-CAM Guidance Package Appliance

A CAD-CAM guidance package appliance could be custom produced by adental professional in an unprecedented way providing solutions to avariety of conditions and or combinations of conditions and at asignificant lesser expense to both the dental professional and thepatient. The dental professional may have a broad spectrum of 3Dpatterning available to guide the patient's mandible to the chosendestination by a route among a broad spectrum of 3D routes.

Embodiments of the methods described herein can be applied to a widerange of stock guidance packages, and/or a stock guidance package thatis then modified by the dental professional, and/or a custom designedguidance package for a specific patient. The guidance package chosen,chosen and modified, or designed could be one of many possibilities ofsize, shape or style to address a very wide range of problems ormalocclusions. The maxillary guidance component and/or the mandibularguidance component of the guidance package can be chosen, chosen andmodified, or designed to one among many choices of shape or size eitherindividually or as a group to achieve whatever effect the operatordesires. For instance, a TMD therapist may have available to her/him anunprecedented range of options regarding both limits and guidance to themandible. In contrast to other systems, some embodiments of thedisclosed guidance package 4 can provide 3D anterior guidance and limitsto the mandible independent of the condition, position, presence orabsence of teeth. Also uniquely attributable to the guidance package,the position of the guidance package (and therefore guidance and limitsof the mandible within the guidance package retentive piece system) canbe controlled to maximize or minimize different properties of theguidance package derived appliance to include increased or decreasedmechanical advantage over the muscles of mastication in excursions. Insome embodiments, the guidance package may be indexed and attached toretentive pieces within the retentive piece system, not directly toteeth or the arches. Considering the unprecedented choices, modificationand design potential of the guidance package, and the flexibilityregarding the position of the guidance package within the retentivepiece system, the CAD-CAM guidance package appliance to include theCAD-CAM guidance package bruxism appliance, the CAD-CAM TMD appliance,and the CAD-CAM sleep apnea appliance are advantageous over existingnight guards, TMD appliance systems, and sleep apnea appliance systems.

The CAD-CAM guidance package appliance may be a two-piece, customized,comfortable to wear, seamless, light-weight, minimal vertical dimensionat rest in CR (or a different index position of the dentalprofessional's choosing) appliance that provides 3D anterior guidanceand limits.

In some embodiments, the guidance package may be placed or indexed (andtherefore 3D guidance placed within a broad range transversely,sagittally, and frontally on the retentive piece system) anterior,posteriorly or laterally to the teeth and therefore not in between theteeth so the material which provides the guidance may not add anyvertical height to the appliance to allow an appliance of minimalvertical dimension at rest. Further, because the guidance may be locatedeven further anterior to the muscles of mastication than teeth, aguidance package equipped appliance may have inherent superiormechanical advantage over the muscles of mastication in excursions ascompared to any guidance involving teeth or built on teeth. In someembodiments, the guidance package may be indexed and attached toretentive pieces within the retentive piece system, not directly toteeth or the arch. In contrast to existing night guards, TMD treatmentsystems, and sleep apnea treatment systems, the CAD-CAM guidance packageappliance may have a broad range of 3D flexibility in the choice,modification and design of the anterior guidance and limits. Further,the CAD-CAM guidance package appliance to include bruxism, TMD and sleepapnea applications can be produced without regard to the condition,presence or absence of teeth, to include anterior teeth, because theguidance is provided entirely by the guidance package.

In the event the patient's CAD-CAM guidance package appliance is lost ordestroyed, a digital record may exist to recreate a duplicate appliancequickly, without the need of a new record making appointment. A newCAD-CAM guidance package appliance replacement can be providedconveniently, and with cost savings for the patient.

The CAD-CAM guidance package appliance can be produced less expensivelythan traditional methods of the dentist and his lab manually producingand adjusting a splint. The CAD-CAM guidance package appliance is asuperior appliance for addressing TMD issues, bruxism, and sleep apnea.The CAD-CAM guidance package appliance in contrast to all existingsystems will provide a superior system to the patient, with greaterconvenience for the patient, and at a better price.

Embodiments of the disclosed methods for producing a customized guidancepackage equipped appliance may be more convenient, less expensive, andless work intensive for both the dental professional and the patient.

In one embodiment, a method of automatically producing or reproducing acustomized guidance package equipped appliance involves combiningdigital methods and/or traditional methods converted to digital tocollect and create information needed to automatically fabricate aspecifically customized guidance package equipped appliance for aspecific patient. When the patient needs a new guidance package equippedappliance due to loss or damage, because the digital record can beretained, a new guidance package equipped appliance can be providedwithout records being collected by the dental professional again.

After the dental and arch information, which is collected from aspecific patient, and the guidance package appliance design is stored ina computer, a new guidance package equipped appliance could be producedby a Computer Numerical Control (CNC) lab, an in office 3D printer orother CAM enabled device, without any further work by the dentist orpatient. Alternatively, if one or two variables regarding the patients'teeth or arch or movement parameters have changed, these could bechanged in the computer records, the design changed accordingly and thensent to a CNC lab, 3D printer or other CAM enabled device, and a newguidance package equipped appliance could be produced without thenecessity of a complete records collection session by the dentist andpatient.

Procedure of Making a CAD-CAM Guidance Package Appliance

In one example embodiment, the procedure for the collection and creationof a patient's dental information record may include: gathering 3Dinformation of both maxillary and mandibular arches; identifying anindex position; setting the patient's virtual 3D maxillary andmandibular teeth and arch at the index position (e.g., CR) at anappropriate vertical dimension (e.g., providing enough space betweenteeth to provide clearance for guidance components (e.g., virtualretentive pieces and/or movement and stop profiles), or the point ofrest, and if necessary, inputting the TMJ/condylar records into thevirtual articulator; identifying the boundaries of an envelope region(3D region); defining movement parameters and, if necessary, performingcollision (e.g., interference) detection to identify movementrestrictions; identify a point in space (virtual point) to place theguidance package relative to the retentive pieces; optionally performingvirtual functional simulation; optionally, virtually applying virtualshelves/protrusions to modify available surfaces for a final solution;designing one or more optional final solutions. The designed finalsolutions may be provided to a manufacturer (e.g., a CAD-CAMmanufacturer) for production.

Gathering 3D information of the maxillary and mandibular teeth andarches, may involve using traditional methods (e.g., making impressionsof the patients' teeth and arches and then pour in stone to make modelsand convert to digital by scanning the models) or directly recording the3D information of the maxillary and mandibular teeth and arches with anin-office scanner or other data acquisition device.

Identifying the prescribed index position (maximum closure position) ofthe mandible in relation to the maxilla. For example, in a case of adental professional intending to use a simple bruxism guidance package4-S (e.g., as shown in FIGS. 2 to 4 ), or a “canine guidance” bruxismguidance package 4-C (e.g., as shown in FIG. 9 ) or a “group function”bruxism guidance package 4-G (e.g., as shown in FIG. 10 ), the dentalprofessional may determine a CR position of the mandible at theappropriate vertical dimension as the index position, which may involveusing traditional methods (e.g., by manipulating the mandible into CRhinge axis and closing the mandible to the appropriate verticaldimension). Other methods to identify the index position of the mandibleto be therapeutic for bruxism include radiography, 3D radiography,sonography, MRI, JMA, and other methods of data collection. Next, thedental professional will make an index of that relationship of the teethand arches (e.g., mounting the models of teeth and arches together inthat relationship) and converting the relationship to digital byscanning the mounted models or directly recording the relationship ofthe maxillary and mandibular teeth and arches of the mandible in theindex position. The dental professional may also use a combination of 3Dradiography combined with intraoral scanning. The 3D radiography may becorrelated or indexed with the intraoral scanning data and coincident toCR position of the mandible 8-1 at the appropriate vertical dimension asinterpreted by the dental professional through 3D radiography, and thatprescribed position of the teeth and arches may be recorded when themandible is in CR directly using the correlated intraoral scanning data.In some cases, the index position may be determined or selectedvirtually. For a guidance package bruxism appliance, the dentalprofessional may use average TMJ values or gather TMJ records usingtraditional methods and/or by using axiography and/or a Jaw MotionAnalyzer, as shown in FIG. 14 . These records may include, but are notlimited to, facebow transfer, inter-condylar distance, condylaryinclination, Bennet angle and border limits (range of motion). FIG. 14shows an example Jaw Motion Analyzer system 23, which enables thecollection of these data and visualization of jaw movement of a patientin real time. It may include an upper receiver 23-1 that is mounted onthe upper face defining parameters to include the locations of the TMJsof a patient, and may be equipped with paramagnetic sensors 23-3. Thisunit may also include a lower receiver 23-4 that is mounted on the lowerj aw of a patient, connected to the mandibular teeth of the patient viaa metal splint 23-5 and another set of paramagnetic sensors 23-6thereon, a converter 23-7 that converts the signal from the sensors23-3, 23-6 to a computer 23-8. In the circumstance of TMD guidancepackage (e.g., as shown in FIGS. 11A, 12A, 12B, 13A and 13B) appliance,additional records may be collected regarding the damage profile of thatpatient to include radiography, 3D radiography, MRI, sonography, JMA orcollection of TMJ records in a traditional way with a manual articulatorcombined with clinical observation of the pain and damage profile,and/or other methods.

As another example, in the case of a TMD guidance package appliance, thedental professional may establish the appropriate position of rest(prescribed maximum closure position) by one or more methods. Forexample, the dental professional can manually manipulate the patient'smandible as a part of his direct clinical evaluation establishing theappropriate position of rest (prescribed maximum closure position) whenthe mandible is closed, through communicating directly with the patientand clinical judgment. The dental professional may then record therelative relationship of the mandible to the maxilla at that position ofrest (prescribed maximum closure position) by scanning the models of theteeth and arches that have been made from the patient in that positionor directly record that relationship between maxillary and mandibularteeth and arches in that position with an in-office scanner. The dentalprofessional may also use a combination of 3D radiography combined withintraoral scanning. The 3D radiography may be correlated or indexed withthe intraoral scanning data. The dental professional may interpretthrough 3D radiography the damage profile of that patient to include thetherapeutic position of rest (prescribed maximum closure position). Thedental professional may record that relative relationship of themandible to the maxilla at that position of first contact of the teethat rest using the correlated intraoral scanning data. Some types of TMJand stomatognathic damage may be recorded with alternative imaging suchas MM (Magnetic Resonance Image), sonography, and/or a Jaw MotionAnalyzer (JMA). The alternative imaging and data collection may becombined with traditional methods of making indexed models of patients'teeth in the designated position of rest (prescribed maximum closureposition) and then scanning or directly record that position with anin-office scanner.

As another example, in the case of a bilateral anterior discdisplacement in which the dental professional intends to use a“bilateral anterior repositioning” TMD guidance package 4-TB, the dentalprofessional may identify, for example, through manual manipulation ofthe mandible, direct communication with the patient, and clinicaljudgment, where the mandible (using the teeth and arches for indexing)should be indexed at rest (prescribed maximum closure position) to themaxilla (using teeth and arches for indexing), protrusively, laterally,and vertically to recapture the discs of both TMJs 9 R and L. The dentalprofessional may advance the mandible protrusively enough from the CRposition so that the condyles 8 R and L of the mandible 8-1 willrecapture both the right and left discs within their respective TMJs 9 Rand L. Other methods to identify the position of the mandible to betherapeutic include radiography, 3D radiography, sonography, MM, JMA,and other methods of data collection.

In some cases, damage (e.g., anterior displacement) of the discs may beof equal distance anteriorly from their respective CR positions so thatthe recapture of the discs may require the same protrusive distanceanterior from CR position of each respective condyle 8 R and L withineach respective TMJ 9 R and L. Further, the damage (e.g., anteriordisplacement) of the discs may not be of equal distance anteriorly fromtheir respective CR positions so that the recapture of the discs mayrequire different protrusive distances when comparing the right condyleprotrusively from CR position of the right TMJ to the left condyleprotrusively from CR of the left TMJ.

If the protrusive value (e.g., distance) of the two condyles torecapture their respective discs is equal, there may not be any lateralmovement of the mandible and the mid-sagittal plane of the mandible willremain coincident with the mid-sagittal plane of the maxilla.

If the right and left protrusive values (e.g., distances) of the twocondyles to recapture their respective discs are different, then thelateral value of the rest position (prescribed maximum closure position)of the mandible may be either to the right or left of the mid-sagittalplane of the maxilla.

If the left condyle 8L must travel relatively further than the rightcondyle 8R protrusively to recapture its relative disc, then the lateralswing positioning of the mid-sagittal plane of the mandible may belocated to the right of the mid-sagittal plane of the maxilla 26proportionally to the relative differential distances traveled by thecondyles to recapture their discs respectively bilaterally. FIG. 11Cshows the example indexing of the mandible right laterally to themaxilla.

If the right condyle 8R must travel relatively further than the leftcondyle 8L protrusively to recapture its relative disc then the lateralswing positioning of the mid-sagittal plane of the mandible may belocated to the left of the mid-sagittal plane of the maxilla 26proportionally to the relative differential distances traveled by therespective condyles to recapture their discs bilaterally. FIG. 11B showsan example indexing of the mandible left laterally to the maxilla.

The vertical value may be the first contact (e.g., contact position ofthe worst interference) of teeth and arches for this protrusive andlateral position of the mandible already established to recapture thediscs bilaterally to include a threshold distance if appropriate

The dental professional can then record the relative relationship of themandible to the maxilla at that position of rest (prescribed maximumclosure position) using traditional methods discussed above orvirtually. Some types of TMJ damage may be recorded with alternativeimaging such as MRI, sonography, and/or a Jaw Motion Analyzer FIG. 14 .Alternatively, the position of rest (prescribed maximum closureposition) may be recorded using alternative imaging combined withtraditional methods of making indexed models of patient's teeth in thedesignated position of rest and then scanning or directly record thatposition with an in-office scanner or other data acquisition device.

In the case of sleep apnea in which the dental professional intends touse a “bilateral anterior repositioning” guidance package 4-TB, thedental professional may identify through manual manipulation of themandible, direct communication with the patient, and/or clinicaljudgment, where the mandible should be indexed at rest (prescribedmaximum closure position; therapeutic for sleep apnea) to the maxilla(e.g., using teeth and arches for indexing), protrusively, laterally,and vertically to anteriorly (protrusively) relocate the mandible to geteffective airway opening. The dental professional may use a Georgegauge, a Thornton Adjustable Positioner or Pro Gauge or other gauge, orother tools including radiography, 3D radiography, sonography, MRI, JMA,and other methods of data collection to identify the best therapeuticposition of the mandible for sleep apnea. For a guidance package sleepapnea appliance, when the dental professional intends to use a“bilateral anterior repositioning” TMD guidance package, as shown inFIG. 11A, the dental professional may use average TMJ data or gather TMJrecords for a particular patient using traditional methods and/or byusing axiography and/or a Jaw Motion Analyzer, as shown in FIG. 14 .These records may include, but are not limited to, facebow transfer,inter-condylar distance, condylary inclination, Bennet angle and borderlimits (range of motion).

The dental professional may advance the mandible symmetricallyprotrusively about 50 to 70% of the maximum protrusive potential of thatpatient from the CR position so that the mandible, and therefore thetongue, is relocated adequately forward to effectively open the airway.

The vertical value may be the first contact (e.g., contact position ofthe worst interference) of teeth and arches for this protrusive andlateral position of the mandible already established to open the airwayeffectively and could also include a threshold distance.

The dental professional can then record the relative relationship of themandible to the maxilla at that position of rest (prescribed maximumclosure position) using traditional methods of creating models of thepatient's teeth in that position and convert to digital by scanning themounted models or directly record the relationship of the maxillary andmandibular teeth and arches in that position of rest (prescribed maximumclosure position) using an in office scanner or other data acquisitiondevice

In the case of a unilateral anterior disc displacement in which theoperator intends to use a “asymmetric protrusive” TMD guidance package4-TU (e.g., as shown in FIG. 12A and FIG. 12B), the dental professionalmay identify through manual manipulation of the mandible, directcommunication with the patient, and clinical judgment, where themandible should be at rest protrusively, laterally and vertically (3Dly)to recapture the disc of the damaged TMJ while leaving the other condyle(of the other TMJ) in a relatively normal albeit rotated position. Othermethods to identify the position of the mandible to be therapeuticinclude radiography, 3D radiography, sonography, MRI, JMA, and othermethods of data collection.

If the damaged disc (e.g., anteriorly displaced disc) is within the leftTMJ, the dental professional may advance the mandible protrusivelyenough to advance the left condyle from the CR position to recapturethat disc, while simultaneously swinging the mandible laterally to theright to allow the right condyle of the right TMJ to stay in its CR orrest position which will also rotate that condyle. Both the final rightlateral swing position of the mandible, which will position themid-sagittal plane of the mandible to the right of the mid-sagittalplane of the maxilla 26, and the rotation of the right condyle may beproportional to the distance traveled by the left condyle to recaptureits disc, as shown in FIG. 11C.

If the damaged disc (e.g., anteriorly displaced disc) is within theright TMJ 9R, the dental professional may advance the mandibleprotrusively enough to advance the right condyle from its' CR positionto recapture that disc, while simultaneously swinging the mandiblelaterally to the left to allow the left condyle 8L of the left TMJ 9L tostay in its CR or rest position which will also rotate that condyle.Both the final left lateral swing position of the mandible 8-1, whichwill position the mid-sagittal plane of the mandible to the left of themid-sagittal plane of the maxilla 26, and the rotation of the leftcondyle 8L may be proportional to the distance traveled by the rightcondyle 8R to recapture its disc, as shown in FIG. 11B.

The vertical value may be the first contact (e.g., contact position ofthe worst interference) of teeth and arches for this protrusive andlateral position of the mandible that may include a threshold distancealready established that will recapture the disc within the damaged TMJand leave the other condyle within the undamaged TMJ in a relativelynormal albeit rotated position.

The dental professional can then record that relative relationship ofthe mandible to the maxilla at that position of rest (prescribed maximumclosure position) using traditional methods of creating models of thepatient's teeth in that position and convert to digital by scanning themounted models or directly record the relationship of the maxillary andmandibular teeth and arches in that position of rest using an in-officescanner.

The dental professional may also use a combination of 3D radiographycombined with intraoral scanning. The 3D radiography may be correlatedor indexed with the intraoral scanning data. The dental professional mayinterpret through 3D radiography and/or a Jaw Motion Analyzer FIG. 14the damage profile of that patient to include where the mandible shouldbe at rest protrusively, laterally and vertically (3Dly) in reference tothe maxilla to recapture the disc of the damaged TMJ, while leaving theother condyle (of the other TMJ) in a relatively normal albeit rotatedposition. The dental professional may record that relative relationshipof the mandible to the maxilla at that position of rest using thecorrelated intraoral scanning data. Some types of TMJ damage may berecorded with alternative imaging such as MRI and sonography.Alternatively, the position of rest (prescribed maximum closureposition) may be recorded using alternative imaging combined withtraditional methods of making indexed models of the patient's teeth inthe designated position of rest (prescribed maximum closure position)and then scanning or directly record that position with an in-officescanner or another data acquisition device.

In the case of various other damage to the stomatognathic system inwhich the dental professional wants to protect or treat damage to anyone or combination of other structures to include damage to a TMJ, orthe muscles, ligaments, or tendons of mastication unilaterally, or otherclinical problems in which the dental professional needs the ability tocontrol the movements and limits of the front end of the mandibleasymmetrically or symmetrically in nontraditional pathways and intendsto use an “asymmetric” TMD guidance package, the dental professional mayidentify the best position of rest (prescribed maximum closure position)for the appropriate therapeutic treatment of the mandible, TMJ, or otherstomatognathic malady of the mandible for that patient through manualmanipulation of the mandible, direct communication with the patient, andclinical judgment, where the mandible should be at rest protrusively,laterally, and vertically (3Dly) to treat or protect a TMJ, or themuscles, ligaments, or tendons of mastication, or various other clinicalproblems or combinations of clinical problems. Other methods to identifythe position of the mandible to be therapeutic include radiography, 3Dradiography, sonography, MM, JMA, and other methods of data collection.

In this example, as shown in FIG. 13A, the damaged structure is adamaged ligament on the right side of the mandible. The dentalprofessional may advance the mandible protrusively enough to advance theright condyle 8R from the CR position to protect the damaged ligament,while simultaneously swinging the mandible laterally to the left toallow the left condyle 8L of the left TMJ 9L to stay in its CR position,which will also rotate that condyle. Both the final left lateral swingposition of the mandible 8-1, which will position the mid-sagittal planeof the mandible to the left of the mid-sagittal plane of the maxilla 26(as shown in FIG. 11B), and the rotation of the left condyle 8L may beproportional to the distance traveled by the right condyle 8R to protectthe damaged ligament.

Another example situation for using an “asymmetric” TMD guidance packageappliance may be to treat a damaged structure on either the left orright side of the stomatognathic system. In this example, there may be adamaged ligament lateral to the mid-sagittal plane of the mandible. Thedental professional may position the mandible protrusively in a positionto protect the damaged ligament. This may be an index position in whichthe mid-sagittal plane of the mandible is lateral to the mid-sagittalplane of the maxilla. The final lateral swing position of the mandible8-1, which will position the mid-sagittal plane of the mandible to theright or left of the mid-sagittal plane of the maxilla 26 (as shown inFIG. 11B and FIG. 11C may be proportional to the relative distancestraveled by each condyle to protect the damaged ligament. The verticalvalue may be the first contact that may include a threshold distance(e.g., contact position of the worst interference) of teeth and archesfor this protrusive and lateral position of the mandible alreadyestablished that will protect the damaged ligament. Other methods toidentify the position of the mandible to be therapeutic to treat adamaged structure include radiography, 3D radiography, sonography, MRI,JMA, and other methods of data collection.

The dental professional can then record that relative relationship ofthe mandible to the maxilla at that position of rest (prescribed maximumclosure position) using traditional methods of creating models of thepatients' teeth in that position and convert to digital by scanning themounted models or directly record the relationship of the maxillary andmandibular teeth and arches in that position of rest (prescribed maximumclosure position) using an in-office scanner or another data acquisitiondevice. Alternatively, 3D radiography with correlated intraoral scanningmay be used to record position of rest (prescribed maximum closureposition). The 3D radiography is correlated or indexed with theintraoral scanning data. The dental professional may interpret using 3Dradiography the damage profile of that patient to include where themandible should be at rest protrusively, laterally and vertically (3Dly)to protect the damaged mandibular structure. The dental professional mayrecord that relative relationship of the maxilla to the mandible at thatposition of rest (prescribed maximum closure position) using thecorrelated intraoral scanning data. Some types of TMJ and stomatognathicdamage may be recorded with alternative imaging such as MRI, sonography,and/or a Jaw Motion Analyzer. Alternatively, the position of rest(prescribed maximum closure position) may be recorded using alternativeimaging combined with traditional methods of making indexed models ofpatient's teeth in the designated position of rest (prescribed maximumclosure position) and then scanning or directly record that positionwith an in-office scanner.

Setting the patient's virtual 3D maxillary and mandibular teeth and archin the index position (CR) at an appropriate vertical dimension data, orthe point of rest (an example predetermined index position; a prescribedmaximum closure position) may include the operator choosing data intothe virtual articulator-CAD program, which may be already stored in acomputer. The digital models of the patient's maxillary and mandibularteeth and arches may be virtually positioned on the Virtual Articulator24 to set up a screen visualizing a Virtual Articulator 24 withpatient's virtual models 25.

The TMJ/condylar records may be set in the virtual articulator-CADprogram, with the records collected from the patient or use averagemeasures. In the case of a TMD patient, additional TMJ data may beplaced in the Virtual Articulator 24 regarding the damage or maladyprofile of that patient. This damage profile data may have beencollected in the clinical exam, radiographic information, MRI, JMA orsonography. This additional information can be added to modify themovement parameters of the TMJs.

Identifying the boundaries of an envelope region (3D region) (e.g.,virtually applying the maxillary retentive piece 27 and the mandibularretentive piece 28 to both arches of maxillary 22 and mandibular 20 at adetermined thickness (e.g. 1 mm)). A 3D space may be defined as a global3D region to include the space for the retentive pieces, the guidancepackage, and all other functions of the guidance package system (guides)or may be defined as a limited 3D region for manipulation of theguidance package only (e.g., in between the retentive pieces). Thevirtual retentive pieces 10 separately to maxillary arch 22 andmandibular arch 20 based on the Class of the malocclusion of the patientas shown in the FIGS. 6, 7 and 8 . For a patient that does not have asevere malocclusion, Class I, retentive pieces 10 may be applied to bothmaxillary arch 22 and mandibular arch 20 as shown in FIG. 6 .

FIG. 15 shows an example computer screen of a Virtual Articulator/CADsystem 24 when virtual models 25 of the patient's teeth and arches areset up based on the input data from a patient, who has a Class Iocclusion, which was collected from step I-a and b, and the virtualretentive pieces have been applied to the virtual models. In a casewhere virtual retentive pieces 27 and 28 are applied in the VirtualArticulator 24, the method may further include animating and measuringthe jaw movements to include laterotrusion to all border limits of themandible (full range of motion).

The method may further include defining movement parameters andperforming collision (e.g., interference) detection in order to identifythe movement restrictions. These movement restrictions, contact pointsand depths may be identified. For a TMD guidance package appliance. Theadditional TMJ data may alter the overall movement parameters, movementrestrictions, contact points and depths.

Identifying a point in space (virtual point) to place the guidancepackage relative to the retentive pieces may be automated or operatordetermined. As the placement and orientation of the guidance packagebecomes more automated, the more likely subsequent adjustments to theguidance package will be necessary. Alternatively, the virtual point maybe placed optimally 3Dly so that a guidance package may be used withoutmodification or to minimize modification. (FIGS. 24-27 ). The virtualpoints (FIGS. 24-27 ) may represent one point for positioning of theguidance package or may represent a vector or three or more points forboth positioning and orientating the guidance package.

In one embodiment, the virtual point(s) may be positioned at a specificdistance (in some examples about 6 mm) anterior to the most anterioraspect of the maxillary retentive piece along the occlusal plane (aplane passing through the occlusal surfaces of the maxillary teeth)mid-sagittally 26). In some embodiments, the point in space may bebetween about 1 mm to about 10 mm anterior to the most anterior aspectof the maxillary retentive piece, depending on the size of the patient'sstomatognathic system and the range of motion of the patient's mandible.In some embodiments, the virtual point may be placed optimally 3Dly sothat a guidance package may be used without modification or to minimizemodification. FIG. 16 shows the relative position of an example virtualguidance package 4 on a maxillary occlusal plane mid-sagittally 26.

FIG. 17 shows an example guidance package 4 relative to the retentivepieces 27, 28 according to the relative position in FIG. 16 . The dentalprofessional may virtually place point 2 (see FIGS. 2A, 4, 16, and 17 )of a guidance package 4. Virtually place point 2 at this point in spacepositioned at a specific distance (in some examples about 6 mm) anteriorto the most anterior aspect of the maxillary retentive piece. Point 2may represent where protrusion 7 of the mandibular guidance component1-2 sits at rest in the maxillary guidance component 1-1 when thecondyles 8 R and L of the TMJs 9R and 9L of the mandible 8-1 are intheir CR positions (e.g., the jaw is in its virtual CR), developedvertically to provide a threshold clearance (in some cases 1 mm orgreater) of space between the retentive pieces (where they wouldotherwise contact).

In another embodiment, for instance as an example in the construction ofa sleep apnea guidance package appliance, using a “bilateral anteriorrepositioning” TMD guidance package 4-TB (e.g., as shown in FIG. 11A),the dental professional may virtually place point 2″ at a point in spacepositioned at a specific distance (in some examples about 6 mm) to themost anterior aspect of the maxillary retentive piece. The location ofPoint 2″, 7″ (e.g., position of rest; prescribed maximum closureposition) may be coincident to a position of the mandible protrusively,laterally and vertically to provide effective airway opening, and toprovide a threshold clearance (in some examples about 1 mm or greater)of space between the retentive pieces (where they would otherwisecontact).

For an alternative bruxism appliance, such as the “canine guidance”guidance package 4-C (e.g., as shown in FIG. 9 ) bruxism appliance,virtually place points 2 a and 2 b equidistant bilaterally, dependentupon size of the guidance package 4-C, from a point positioned at aspecific distance (in some examples about 6 mm) anterior to the mostanterior aspect of the maxillary retentive piece. In some embodiments,the points 2 a and 2 b may be between about 1 mm to about 10 mm anteriorto the most anterior aspect of the maxillary retentive piece, dependingon the size of the patient's stomatognathic system and the range ofmotion of the patient's mandible. Points 2 a and 2 b may represent wherethe protrusions 7 a and 7 b of the mandibular guidance component 1-2-Csits at rest in the maxillary guidance component 1-1-C when the condyles8R and 8L of the TMJs 9R and 9L of the mandible 8-1 are in their CRpositions (e.g., the jaw is in its virtual CR), developed vertically toprovide a threshold clearance (in some examples 1 mm or greater) ofspace between the retentive pieces (where they would otherwise contact).

For another alternative bruxism appliance, such as a “group function”guidance package 4G (e.g., as shown in FIG. 10 ) bruxism appliance,virtually place point 2′ at a point positioned at a specific distance(in some examples about 6 mm) anterior to the most anterior aspect ofthe maxillary retentive piece. In some embodiments, the point 2′ may bebetween about 1 mm to about 10 mm anterior to the most anterior aspectof the maxillary retentive piece, depending on the size of the patient'sstomatognathic system and the range of motion of the patient's mandible.Point 2′ may represent where the mandibular guidance component 1-2-G 7′sits at rest in the maxillary guidance component 1-1-G when the condyles

8R and 8L of the TMJs 9R and 9L of the mandible 8-1 are in their CRpositions (e.g., the jaw is in its virtual CR), developed vertically toprovide a threshold clearance (in some examples 1 mm or greater) ofspace between the retentive pieces (where they would otherwise contact).

In other embodiments, for instance as an example in the construction ofa guidance package appliance, such as a “bilateral anteriorrepositioning” TMD guidance package 4-TB (e.g., as shown in FIG. 11A)appliance, virtually place point 2″ at a point positioned at a specificdistance (in some examples about 6 mm) in space anterior to the mostanterior aspect of the maxillary retentive piece. In some embodiments,the point 2″ may be between about 1 mm to about 10 mm anterior to themost anterior aspect of the maxillary retentive piece, depending on thesize of the patient's stomatognathic system and the range of motion ofthe patient's mandible. The location of Point 2″, 7″ (e.g., position ofrest; prescribed maximum closure position) may be coincident to aposition of the condyles 8R and 8L within the TMJs 9R and 9L other thanCR, developed protrusively, laterally and vertically to recapture thediscs of both TMJs 9R and 9L and to provide about 1 mm or greater ofspace between the retentive pieces (where they would otherwise contact).

In the case of the construction of a “asymmetric protrusive” TMDguidance package 4-TU (e.g., as shown in FIG. 12A) appliance, virtuallyplace points 2′a and 2′b at a distance and asymmetrically bilaterally,dependent upon size of the guidance package 4-TU, from a pointpositioned at a specific distance (in some examples about 6 mm) anteriorto the most anterior aspect of the maxillary retentive piece. In someembodiments, the points 2′a and 2′b may be between about 1 mm to about10 mm anterior to the most anterior aspect of the maxillary retentivepiece, depending on the size of the patient's stomatognathic system andthe range of motion of the patient's mandible. The location of points2′a and 2′b (e.g., position of rest) may be coincident to some positionof the condyles 8R and 8L within the TMJs 9R and 9L other than CR,developed protrusively, laterally, vertically and asymmetrically so thatthe damaged TMJ has recaptured its' disc and the other TMJ is in arelatively normal albeit rotated state.

In the case of the construction of a “asymmetric” guidance package 4-AT(e.g., as shown in FIGS. 13A and 13B) appliance, virtually place point2′″ laterally right or left, at a distance dependent upon size, shapeand orientation of the guidance package 4-AT, from a point positioned ata specific distance (in some examples about 6 mm) anterior to the mostanterior aspect of the maxillary retentive piece. In some embodiments,the point 2′″ may be between about 1 mm to about 10 mm anterior to themost anterior aspect of the maxillary retentive piece, depending on thesize of the patient's stomatognathic system and the range of motion ofthe patient's mandible. The location of Point 2′″ (e.g., position ofrest; prescribed maximum closure position) may be determined by thedental professional for therapeutic treatment of the mandible, TMJ, orother stomatognathic malady of the mandible for that specific patient.

This point of reference (virtual point[s]) for the placement of point orpoints 2, 2′, 2″, 2′ 2 a, 2 b, 2′a, and 2′b of the virtual guidancepackage could be any of the dental professional's choosing (FIGS. 24-27) based on multiple variables, for example malocclusion, verticaldimension of rest consideration, and mechanical advantage over musclesof mastication consideration.

For a severe Class II malocclusion patient, this point or points 2, 2′,2″, 2″, 2 a, 2 b, 2′a, and 2′b of the virtual guidance package could beplaced more posterior (e.g., as shown in FIG. 7 ).

For a severe Class III patient, point or points 2, 2′, 2″, 2″, 2 a, 2 b,2′a, and 2′b of the virtual guidance package could be placed furtheranterior (e.g., as shown in FIG. 8 ).

The dental professional could at this point virtually construct aguidance package of any design around Point 2, 2′, 2″, 2′″ or points 2 aand 2 b, or 2′a and 2′b and their still oriented mandibular components1-2, 1-2-C, 1-2-G, 1-2-TB, 1-2-TU, 1-2-AT as shown in FIGS. 1, 9, 10,11A, 12A, 12B, 13A and 13B. All parameters of size, shape, depth,steepness, and style of guidance can be controlled to include placementof lateral guidance 5, protrusive guidance 6, and special protrusiveguidance 6 a, as shown in FIGS. 2A-C, 9, 10, 11, 12A, 12B, 13A and 13B.The mandibular component may be modified regarding the number ofprotrusions, and the size and shape of those protrusions. The dentalprofessional may use the border limits (range of motion) of the mandibleto define the overall size of the retentive piece(s) and/or guidancepackage 4. The depth 32 of the guidance package, shown in FIG. 1 , canbe controlled. The steepness 33, shown in FIG. 1 , of the guidance canbe dictated by the dental professional. In some cases, for instance asan example a TMD guidance package, the guidance may be asymmetrical,specialized protrusive guidance may be included 6 a (e.g., as shown inFIGS. 11A, 12A and 12B), or the range of motion could also be prescribedasymmetrically (e.g., as shown in FIGS. 12A, 12B, 13A and 13B). Thedental professional may have a broad spectrum of 3D patterning availableto guide the patient's mandible to a selected destination by a routechosen or designed from a broad spectrum of 3D routes available.

Alternatively, the dental professional could choose a guidance packagefrom a library of stock virtual guidance package designs of differentsizes and shapes. In other embodiments, the dental professional couldchoose and then modify a stock virtual guidance package from a virtuallibrary.

The dental professional could choose an appropriate stock virtualguidance package from the virtual library and use without modification.As an example, the most common application for a bruxism guidancepackage appliance would be to select a stock virtual guidance packagethat is large enough to provide anterior guidance to avoid allinterferences (e.g., collisions, movement restrictions) in a symmetricalway, provide mechanical advantage over the muscles of mastication, andprovide a preferable minimum vertical dimension at rest in CR position.

Once the guidance package has been virtually modeled or chosen from alibrary and/or modified, a virtual functional simulation on the virtualarticulator of the anterior guidance provided by the virtual guidancepackage may be performed to verify the dental professional's goals. Manyoptions are available in treating TMD. For a TMD guidance packageappliance goals could include special protrusive, lateral, and verticalguidance to manage the specific damage profile of a specific patient. Inthe case of a “bilateral anterior repositioning TMD guidance package4-TB appliance, the objectives may be that as the patient closes his jawspecial protrusive guidance is provided to bring the mandible to aposition of rest 2′, 7′ that will recapture both discs and from thatposition of minimal vertical dimension at rest all excursions from thatposition will guide the mandible to avoid all interferences and guidethe mandible in specific 3D pathways meant to therapeutically addressthe damage profile of that particular patient.

In the case of sleep apnea therapy using a “bilateral anteriorrepositioning” TMD guidance package 4TB, as shown in FIG. 11A,appliance, the objectives may be that as the patient closes his jawspecial protrusive guidance is provided to bring the mandible to aposition of rest 2′, 7′ that will open the airway effectively to treatsleep apnea, and from that position of minimal vertical dimension atrest all excursions from that position will guide the mandible to avoidall interferences and guide the mandible in specific 3D pathways meantto therapeutically address the sleep apnea of that particular patient.

In the case of a “asymmetric protrusive” TMD guidance package 4-TU(FIGS. 12A and 12B) appliance, the objectives may be that as the patientcloses his jaw special protrusive guidance is provided to bring themandible to a position of rest 2′a and 2′b that will recapture the discof the damaged TMJ and leave the other condyle in a relatively normalposition albeit somewhat rotated and from that position of minimalvertical dimension of rest all excursions from that position will guidethe mandible to avoid all interferences and guide the mandible inspecific 3D pathways meant to therapeutically address the damage profileof that particular patient. In the case of an “asymmetric” TMD guidancepackage 4-AT appliance, the objectives may be determined by the operatorfor therapeutic treatment of the mandible, TMJ, or other stomatognathicmalady of the mandible for that specific patient for the position orrest 2″, 7″ and from that position of minimal vertical dimension of restall excursions from that position will guide the mandible to avoid allinterferences and guide the mandible in specific 3D pathways meant totherapeutically address the damage profile of that particular patient.

However most commonly, a dental professional may be creating a guidancepackage bruxism appliance, having goals of the elimination of allposterior interferences therefore eliminating destructive engramsreducing muscle spasms, protection of the teeth and TMJs, an increasedmechanical advantage over the muscles of mastication, a minimal verticaldimension at centric occlusion rest position 2, 2′, 2 a, 2 b, 7, 7′, 7a, and 7 b and ideal 3D anterior guidance from that position creating asuperior anterior guidance bruxism appliance.

The method may optionally include virtually applying one or moreshelves/protrusions as a bridge between the retentive pieces 10 and therespective virtual guidance package components taking care to remaininside the envelope of function of the guidance package on both themaxillary and mandibular aspects of the guidance package appliance 13.The vertical dimension 16 for a patient at rest (prescribed maximumclosure position) of the guidance package appliance 13 in the examplesof FIGS. 6 through 8 can remain minimized irrespective of the Class ofthe malocclusion by fixing the relative position of the virtualshelf/protrusion on the frontal surface of the retentive piece 10 of thecurrent example embodiment that receives the appropriate component ofthe guidance package 4.

The guidance package may enable guidance irrespective of the positionsof the teeth, combined with the virtual retentive piece andshelves/protrusions, which in turn enables the dental professional toplace the guidance package in a location to maximize guidance, maximizemechanical advantage over muscles of mastication, and minimize verticaldimension at rest (see FIG. 5 ).

As shown in FIGS. 7 and 8 , the shelves/protrusions may receive themandibular guidance component 1-2 of the guidance package 4 for a ClassII malocclusion patient and the shelf/protrusion receives the maxillaryguidance component of the guidance package 4 for a Class IIImalocclusion patient. In the construction of a sleep apnea guidancepackage appliance, the dental professional may assume a Class IIImalocclusion point of view in selecting the shelf/protrusion becausethat is the end therapeutic goal. The retentive piece may have multipleprotrusions or shelves in various shapes and sizes that serve asattachment points and/or platforms for all guidance and stop features ofthe guidance packages or generated by guidance packages of the presentdisclosure. For a non-malocclusion case, Class I, as shown in FIG. 6 ,the shelves/protrusions of the retentive piece 10 may be applied as abridge to the respective component of the guidance package for both themaxillary arch 22 and mandibular arch 20.

This data and information, collected from the above steps, may be usedto design a final solution (e.g., an appliance). The design for a finalsolution may be transferred to a manufacturer who has, for example, CAM(Computer Aided Manufacturing) or CNC (Computer Numerical Control)technology and equipment, an in-office 3D printer, or anothermanufacturing or printing system. In some embodiments, a two-pieceCAD-CAM guidance package appliance, a two-piece CAD-CAM TMD guidancepackage appliance, or a two-piece CAD-CAM sleep apnea guidance packageappliance can be automatically produced or re-produced that iscustomized for a specific patient, consisting of a maxillary aspect anda mandibular aspect, which is comfortable to wear, irrespective of themalocclusion type including open bite, deep bite, cross bite, severeClass II, and Class III (see FIGS. 6 to 8 ).

The style, shape, steepness, depth, and size of the guidance packagewhich could be a stock guidance package, a modified from a stockguidance package or specifically designed is dependent upon the problemor combination of problems and the occlusion or malocclusion thatparticular patient exhibits.

FIG. 18 shows an example completed CAD-CAM guidance package appliance ora CAD-CAM TMD guidance package appliance for a patient without a severemalocclusion, Class I, from the inside of the mouth. In this example,both the maxillary retentive piece 27 and mandibular retentive piece 28of the CAD-CAM guidance package appliance may be included of theretentive pieces 10. The maxillary and mandibular guidance packageappliance subsets, including the retentive piece and the guidancecomponent 1-1 or 1-2 of the guidance package, may be connectedseamlessly by the shelves/protrusions.

FIG. 19 shows an example completed CAD-CAM guidance package appliance orCAD-CAM TMD guidance package appliance for a patient with a severe ClassII malocclusion from inside the mouth. For a severe Class IImalocclusion, the mandibular retentive piece 28 may be a retentive piece10, which has a shelf/protrusion to receive the mandibular guidancecomponent 1-2, and the maxillary retentive piece can be a retentivepiece 10, which provides a shelf/protrusion as a platform.

FIG. 20 show an example completed CAD-CAM guidance package appliance,CAD-CAM TMD guidance package appliance for a patient with a Class IIImalocclusion, or a CAD-CAM sleep apnea guidance package appliance frominside the mouth. For a Class III malocclusion or for treatment of sleepapnea, the maxillary retentive piece 27 may be a retentive piece 10,which has a shelf/protrusion to receive the maxillary guidance component1-1, and the mandibular retentive piece can be a retentive piece 10 thatprovides a shelf/protrusion as a platform.

Located in the mouth with a minimal vertical dimension 16 penalty atrest in CR, or any position of the dental professional's choosing, acustom guidance package appliance may be composed of thin custom-fittingretentive pieces and the attached guidance package 4, 4-C, 4-G, 4-TB,4-TU, or 4-AT. The guidance package portion of the appliance 13 may bepositioned in a smooth compartment-like package between the patient'slips, anterior to the teeth in most cases dependent upon themalocclusion, and therefore, the position of the guidance package inrelation to teeth and lips. As the patient's mouth closes, the maxillarycomponent of the guidance package appliance may contact the mandibularcomponent guiding the mandible into Point 2, 2′, 2″, 2′″ or Points 2 aand 2 b, or 2′a and 2′b and area 3, 3′, 3″, 3″ as shown in FIGS. 2A, 4,9, 10, 11A, 12A, 12B, 13A and 13B. This index position area would mostcommonly be CR (e.g., Point 2 in FIG. 4 , Points 2 a and 2 b in FIG. 9 ,Point 2′ in FIG. 10 ) and the long centric area (e.g., Area 3 and 3′ inFIGS. 4, 9, and 10 ) but could in the case of a TMD guidance packagemanagement appliance, a stomatognathic treatment TMD guidance packageappliance, or a sleep apnea guidance package appliance, be a positionother than CR prescribed by the dental professional (e.g., Point 2″ inFIGS. 11A and Point 2″ in FIGS. 13A and 13B, or Points 2′a and 2′b inFIGS. 12A and 12B). The maxillary guidance component 1-1, 1-1-C, 1-1-G,1-1-TB, 1-1-TU, 1-1-AT of the guidance package 4 may fit over themandibular component 1-2, 1-2-C, 1-2-G, 1-2-TB, 1-2-TU, 1-2-AT. Theentire inferior perimeter of the maxillary component of the guidancepackage 4 may be wider than the mandibular component of the guidancepackage and its housing. That perimeter 1-4 in FIG. 2A may also have adesignated thickness (in some examples between about 2 mm to about 6 mm)and be shaped like a bumper to prevent the lips from ever being pinchedwhen the patients' mouth closes. In other embodiments, the perimeter 1-4may have a thickness between about 1 mm to about 10 mm.

Finally, when the various guidance packages 4, 4S, 4-C, 4-G, 4-TB, 4-TU,and 4-AT (e.g., as shown in FIGS. 1, 9, 10, 11A, 12A, 12B, 13A and 13B)appliances for patients with different malocclusions are manufactured bythe CAD-CAM method, all the retentive pieces 27, 28 and their respectiveguidance package components 1-1, 1-1-c, 1-1-G, 1-1-TB, 1-1-TU, 1-1-AT or1-2, 1-2-C, 1-2-G, 1-2-TB, 1-2-TU, 1-2-AT may be produced in one piecewithout any seam lines.

FIG. 21 shows an example finished CAD-CAM guidance package appliance 29,which may have special properties to manage a TMD patient, or anappliance for a bruxism patient without a severe malocclusion, Class Iand with or without sleep apnea. Compared with FIG. 6 , it is simpler toproduce and much simpler to reproduce.

Similarly, FIG. 22 shows an example finished CAD-CAM guidance packageappliance 30 that may have special properties to manage a TMD patient, abruxism patient with Class II malocclusion, or a sleep apnea patientwith a Class II malocclusion. FIG. 23 shows an example CAD-CAM guidancepackage appliance 31, which may have special properties to manage a TMDpatient, a bruxism patient with a Class III malocclusion, or a sleepapnea patient.

FIGS. 24A-24C show an example positioning of the virtual point(s)relative to one or more of the maxillary and mandibular retentive piecesthat provide multiple protrusions or shelves in all shapes and sizesthat serve as attachment points and/or platforms for guidance packagesand/or all the guidance and stop features generated by guidance packagesin the transverse, sagittal, and frontal axes. Virtual point placementmay be automated or operator determined. As the placement andorientation of the guidance package becomes more automated, the morelikely subsequent adjustments to the guidance package will be necessary.Alternatively, the virtual point(s) may be placed optimally 3Dly so thata guidance package may be used without modification (FIGS. 24A-27 ). Thevirtual points (FIGS. 24A-27 ) may represent one point for positioningof the guidance package or may represent a plurality of points for bothpositioning and orientation of the guidance package.

In FIG. 24A, for a patient without a severe malocclusion, Class 1,retentive pieces 10 may be placed on the maxillary arch 22 andmandibular arch 20, with the maxillary arch 22 extending anteriorlybeyond the mandibular arch 20 (albeit slightly). In FIG. 24B, for apatient with a Class II malocclusion, the retentive piece 10 may beplaced on the mandibular arch 20, to provide a shelf/protrusion as anattachment point and may be placed on the maxillary arch 22 to provide ashelf/protrusion as a platform. In FIG. 24C, for a patient with a ClassIII malocclusion or for a sleep apnea appliance, the retentive piece 10may be placed on the mandibular arch 20 to provide a shelf/protrusion asa platform, while the retentive piece 10 may be placed on the maxillaryarch 22 to provide a shelf/protrusion as an attachment point.

Positioned between the arches 20, 22, a plurality of potential virtualpoints 40 may designate contact points between guidance packagemaxillary and mandibular guidance components. In some embodiments, oneor more of the guidance package guidance components may be set based ona virtual point 40 such that when the guidance package guidancecomponents contact, the virtual maxillary and mandibular arches 22, 20are placed in the predetermined index position (prescribed maximumclosure position). In some embodiments, the potential virtual points 40may include one or more interior virtual points 42, edge virtual points44, and anterior virtual points 46. The interior virtual point(s) 42 maynot provide an ideal vertical dimension at rest, may provide the leastmechanical advantage over muscles of mastication, and may interfere withother functions of the mouth. The edge virtual point(s) 44 may notprovide an ideal vertical dimension at rest, may provide limitedmechanical advantage over muscles of mastication, and may or may notinterfere with other functions of the mouth. The anterior virtualpoint(s) 46 may provide optimal placement that enables ideal verticaldimension at rest, the greatest mechanical advantage over the muscles ofmastication, and minimum interference with other functions of the mouth.

FIGS. 25 and 26 provide a 3D view of the example retentive pieces 10 fora patient without a severe malocclusion, Class 1, as shown in FIG. 24A.In FIG. 25 , a single virtual point (e.g., one of the interior virtualpoint 42, edge virtual point 44, or anterior virtual point 46) may bepositioned between the retentive pieces proximate the sagittal axis(e.g., along the mid-sagittal plane). Alternatively, as shown in FIG. 26, a pair of virtual points (e.g., two interior virtual points 42, edgevirtual points 44, or anterior virtual points 46) may be positionedbetween the retentive pieces proximate the sagittal axis (e.g., alongthe mid-sagittal plane). The pair of virtual points may beasymmetrically positioned in relation to the mid-sagittal plane. Thevirtual point(s) may be positioned proximate a vertical planeperpendicular to the mid-sagittal plane. In some embodiments, thevertical plane may be positioned at a specific distance (in someexamples about 6 mm) anterior to the most anterior aspect of themaxillary retentive piece along an occlusal plane mid-sagittally. Thevirtual points indicated may represent one virtual point or a groupingof virtual points that may also enable orientation. In some cases, asingle virtual point may indicate orientation as well as position (e.g.,as a virtual vector).

FIG. 27 shows a plurality of potential locations in all three axes(e.g., sagittal, vertical, and transverse) for a virtual point orpoints, which may better enable an operator to use an unmodified virtualstock guidance package or require less customization of the stockguidance package or designate attachment points for portions of guidancepackage solutions. In other words, allowing a dental practitioner toselect any position in 3D virtual space as the virtual point maximizesthe range of orientation, alignment, and position that a stock (notmodified), or a scaled using patient data guidance package, or a portionof a guidance package may be used to fit a particular patient. As shown,a virtual point 48 may be placed anywhere in 3D virtual space, forexample, such as any of potential virtual point positions 48A-48MM asnon-limiting examples. Although virtual points 48A-48MM are depicted, itwill be understood that these are merely examples and the virtual pointmay be defined in various positions within or exterior to the virtualarches. It is contemplated that, while the virtual point 48 may beproximate mid-sagittal and occlusal planes, it may be placed anywhere in3D space to accommodate any disease, deformity, damage, area requiringtreatment, and the like. Further, a series of guidance packageappliances may be used to progressively treat and/or correct any damage,and the series of guidance package appliances may be virtually designedand produced without requiring extensive customization of physicalappliances by trial and error. In one example embodiment, the firstguidance package appliance in a series may have a virtual pointproximate position 48A, while a later guidance package appliance in theseries may have a virtual point proximate position 48F, which is closerto an example “ideal position” proximate the mid-sagittal and occlusalplanes. In other embodiments, a series of different index positions ofmandible in relation to maxilla are planned, to gradually bring amandible from a particular index position in relation to the maxilla toanother position. A series of appliances could be planned for this majortherapeutic movement over time of the mandible in relation to themaxilla.

FIG. 28 is a flowchart of an example method 50 for preparing a guidancepackage equipped appliance for a patient with one or more of bruxism,TMD, and sleep apnea. As shown, the method 50 may include obtainingpatient data 52 including 3D arch data associated with the patient.After obtaining the patient data, one or more digital models may begenerated 54 on one or more processors based on the patient data, e.g.,in a virtual articulator. The one or more digital models may includevirtual maxillary and mandibular arches in the virtual articulator. Thevirtual arches may be positioned 58 in an index position (prescribedmaximum closure position) for the patient. In some cases, the indexposition includes clearance for guidance features and any retentivepiece.

An envelope region (3D region) may be identified 62, which defines aspace within which a retentive piece and/or guidance package may beutilized. In some cases, a 3D region may be a space defined as thenegative space formed when the mandible and maxilla of the patient areat a point of first contact or when the mandible and maxilla are furtherseparated. In some cases, an envelope region (3D region) may be definedas a space formed between one or more surfaces of positioned retentivepieces. In some cases, a 3D region may be defined as global 3D space orworking space for the retentive piece(s), the guidance package, andother functions of the guidance package system. In some cases, aboundary 3D space may be defined by virtual planar curves. In someembodiments, an envelope region may include tissue or teeth of apatient; in this case, implementing the solution may include surgery orimplants. In some embodiments, an envelope region may be predefined fora particular patient or a particular guidance package. In someembodiments, a system may automatically generate boundaries of anenvelope region (the 3D region) based on one or more of patient data(e.g., tissue surfaces, TMJ data), the curves of occlusion, and the typeof solution. For example, in some cases, for a restoration guidesolution, the system may identify interferences (e.g., an oversizedtooth), and include a portion of the identified interferences within anenvelope region. In other situations, for a one-piece appliancesolution, the system may identify the tissue surface of one arch and a(virtual) retentive piece (or a virtual planar curve) fitted over theopposing arch as defining boundaries of an envelope region.

One or more virtual points may be generated 64 based on the indexposition and/or an envelope region. A virtual guidance package may bepositioned 66 in virtual space based on the one or more virtual points(e.g., location and alignment). The guidance package may include amovement profile that describes how the mandible should move relative tothe maxilla as the mandible closes from the point of first contact tothe index position.

After positioning the guidance package 66 in virtual space, the virtualguidance package may be parameterized 68 to form a virtual guidancepackage equipped appliance. In some cases, one or more retentive piecesmay be parameterized 68 as part of the guidance package equippedsolution. Guidance package equipped appliance production data based onthe virtual guidance package equipped appliance can then be transmitted70. For example, the guidance package equipped appliance production datamay be transmitted to a manufacturer equipped with one or more of CAM,CNC technology, an in-office 3D printer, and other CAM enabled device.

It will be understood that certain elements of the method describedabove may be executed in different orders or executed simultaneously.For example, an envelope region (appropriate 3D space) may be identified62 before the index position is determined.

In some embodiments, there is provided a method including obtaining 3Darch data, obtaining or inputting TMJ data including range of motion ofthe mandible, determining movement parameters and collision (e.g.,interference) detection in order to identify the movement restrictions,understand current patient situation (or obtaining this data using aJMA), establishing an envelope region (e.g., with or without virtualretentive pieces), establishing virtual point(s) based on an indexposition, parameterize a movement profile, and creating one or more ofsurgical, restorative and implant placement guides and retentive pieces(either virtually or through manufacturing) if/as needed (e.g., based ona desired solution).

In some embodiments, there is provided a method including obtaining 3Darch data, obtaining or inputting TMJ data including range of motion ofthe mandible, determining movement parameters and collision (e.g.,interference) detection in order to identify the movement restrictions,understand current patient situation (or obtaining this data using aJMA), establishing virtual point(s) based on an index position,inserting a virtual representation of a guidance package at the indexposition, and creating (e.g., using CAM) one or more solutions (e.g.,appliances or retentive pieces) including a same shape as the guidancepackage.

Parameterization

In some cases, a global 3D space is defined to manipulate retentivepieces, guidance packages, and all other functions of the guidancepackage system. In some cases, a 3D region is created to manipulate onlythe guidance package system, guidance packages may be pre-sized or asize, or relative size and orientation of aspects of guidance componentswithin the guidance package may be determined, scaled using patientdata, or adjusted as needed, and then directly attached to retentivepieces and CAM produced. However, this may not be an appropriate finalform for a specific individual or final purpose. Accordingly, acustomized for a particular patient or a particular purpose movementprofile (e.g., guidance and stop profile) within the virtual articulatormay also be considered a geometrical or mathematical object. Accordingto one or more embodiments, the method can further includeparameterization of the retentive piece and/or include aparameterization of the customized movement profile (geometrical object)within a boundary of an envelope region (a global 3D region or a morelimited 3D region) and selection of different synergistically shapedguidance packages. In other words, a movement profile can be defined fora specific patient, and guidance packages for implementing the movementprofile can be derived therefrom. This mathematical manipulation of theretentive piece(s) and/or the customized guidance and stop profileenable a broad range of products and services for implementing theguidance and stop profiles, including two piece appliances, one pieceappliances, two piece restorations, one piece restorations, surgicalguides, restorative guides, and implant placement guides.

In some cases, an envelope region may be defined by a placement of oneor more retentive pieces 10, for example, as illustrated in FIG. 5 . Insome implementations, the guidance surface 720 of the retentive piece 10may define at least one portion of an envelope region. In otherimplementations, the tissue surface 710 of the retentive piece 10 maydefine at least one portion of an envelope region. In somecircumstances, a portion of the 3D space may be defined as a planarcurve that may or may not correspond to a surface of a virtual and/orphysical retentive piece. The retentive piece 10 may serve as a base forany appliances or restorations developed based on the parameterization.Retentive piece 10 can also be a therapeutic entity that is theninteractive with the guidance and stop system. The retentive piece 10could include clear aligner type orthodontic appliances (e.g.,Invisalign®) (or other type of therapeutic appliance) that when combinedwith the guidance and stop features of the guidance package system willcreate new therapeutic systems. The guidance incorporated with atherapeutic entity could, in some cases, help mitigate user discomfort,or increase the utility of the appliance. In some cases, a clinician maycontrol both orthodontic tooth movement and mandibular relative tomaxillary guidance and stops for new therapies in TMD, orthodontics,orthopedics, and other categories of dentistry and medicine.

A 3D region (envelope region) on a given arch may involve only space onthe guidance side of the retentive piece or may involve tissue that mayor may not be modified on the guidance side of the retentive piece. Inother words, the guidance package system calculates the guidance profileof the mandible to a prescribed maximum closure position. Thiscalculation can involve both the maxillary and mandibular components ofguidance and stops and/or the retentive piece(s). In some circumstances,that calculation will involve not the space between the retentive pieces(including or excluding the retentive pieces) but may involve tissue(i.e., tooth structure, gingiva, bone and/or other tissues) to bemodified. In some cases, calculation will involve tissue that will notbe modified, but must be involved in the calculation. In thiscircumstance that some of the patient's tissue will be involved in thecalculation, a virtual planar curve for that arch (or both arches ifboth arches have tissue involved in the calculation) can be virtuallyembedded within the tissue of that arch far enough so that allparameterizations of a movement profile that the clinician may want touse would be available. Portions of the virtual planar curve may or maynot correspond to a surface of a virtual and/or physical retentivepiece. In some cases, a planar curve may define a boundary of thevirtual 3D region, and may be in the shape of a hyperbolic paraboloid.In some cases, a 3D region (envelope region) may be defined prior tovirtual retentive piece placement by use of a planar curve that may ormay not later correspond to a surface of a retentive piece. For example,consider a case of an oversized tooth, which prevents proper closure. Toprovide additional corrective measures, an envelope region may extendinto the oversized tooth. Certain parameterizations may then depend uponthe tooth being shaved down.

An envelope region (3D region) may be defined for various arch andtissue surfaces. FIG. 29 illustrates various types of arches, includinga dentate arch 2900-a (having all teeth), an edentulous arch 2900-b(having no teeth), a partially dentate arch 2900-c (missing some teeth),an arch of existing dentition, or prosthetics or combination 2900-d(e.g., an arch having some existing dental work), and an atypical arch2900-e (e.g., an arch in transition such as an arch undergoing surgeryor rehabilitation or other circumstances). Envelope regions (virtual 3Dregions) may be defined as the tissue surfaces of the arches, a regionembedded within tissue on the arches, or guidance side surfaces 720 ofretentive pieces, or tissue side surfaces 710 of retentive pieces, orother surfaces of retentive pieces 10 placed or virtually placed aroundthe arches. In some embodiments, the appropriate 3D space may be definedby planar curves that may or may not represent a surface of a virtualand/or physical retentive piece. If utilized, retentive pieces 10 mayuse various attachment mechanisms including compressive material likeplastic or other material, adhesive, wire, vacuum, clasps, bondingmaterials, implants, mini implants, or other appropriate mechanismsbased on the arch and desired retention mechanism (e.g., stainless steelor titanium surgical screws to attach the retentive piece directly tobone of an arch in transition).

The various types of arches depicted in FIG. 29 may apply to either themandible or maxilla. In some cases, the mandible and maxilla may havedifferent arch types.

FIGS. 30A and 30B illustrate two non-limiting examples of potentialsurfaces of virtual retentive pieces partially defining an enveloperegion (3D region) by being placed on the guidance side surface ofarches. FIGS. 30A and 30B illustrate circumstances in which only space(no tissue) exists between the virtual retentive pieces (a 3D region).As shown in FIGS. 24-27, 29, 30A and 30B, the guidance package systemcan use the virtual positions of a surface of, or the entire body of theretentive pieces for guidance package development, and attachment. Theguidance package system can also use the virtual positions of differentsurfaces of the retentive pieces to define a space available (limited 3Dregion) for parametrical manipulation (mathematical calculation) of themovement and stop profile (FIGS. 30A-31D). For example, referring toFIG. 30A, a retentive piece may be in physical form or in virtual formrepresented by a planar curve that may or may not become a surface of aretentive piece.

When all the space is available between the retentive pieces 10 forproducing guidance components for guidance equipped appliances orrestorations, the tissue side 710 of the retentive pieces 10 will be incontact and attached to the guidance side surface of that arch. Examplesof retentive pieces attached to the guidance side surface of the archare shown in FIGS. 30A-30B.

FIG. 30A illustrates dentate mandibular and maxillary arches 3010 a.Retentive pieces 3020 a may be fitted (virtually) onto the arches 3030a. The boundary of the envelope region 3045 a may be defined as thespace between the retentive pieces 3040 a. Guidance mechanisms may beentirely located between the retentive pieces, and may be combined withone or more retentive pieces to form a guidance equipped appliance, suchas a bruxism appliance, a TMD appliance, a sleep apnea device, or arestoration. The guidance and stop features of the one or two pieceappliance or restoration can be constructed between the retentive piecesFIG. 30A. The calculation for and the construction of a two pieceappliance or restoration will include both the retentive pieces and theguidance and stop features for those respective retentive pieces, but inthe case of a one piece appliance will involve only one actual physicalretentive piece for the construction of that one arch solution(appliance or restoration).

FIG. 30B illustrates edentulous mandibular and maxillary arches 3010 bonto which retentive pieces 3020 b are placed 3030 b. An envelope region3045 b is defined by the space between the retentive pieces 3040 b, suchthat guidance mechanisms are entirely located between the retentivepieces, and when combined with the retentive piece(s) may form guidanceequipped appliances (such as canine guidance or group function applianceor restoration). The guidance and stop features of the two pieceappliance or restoration can be constructed between the retentivepieces. The calculation for and the construction of a two pieceappliance or restoration will include both retentive pieces and theguidance and stop features for those respective retentive pieces, but inthe case of a one piece appliance will involve only one actual physicalretentive piece for the construction of that one arch solution(appliance or restoration).

Although retentive pieces are described with reference to FIGS. 30A and30B, one of ordinary skill should recognize that this is merely anexample. In some circumstances, an envelope region (3D region) may bedefined by the tissue surfaces (e.g., teeth, gums), or some gap formedaround the tissue surfaces.

There may be a circumstance regarding an arch or both arches thatinstead of all the guidance and stops and retentive pieces being locatedbetween the tissue of the two respective arches, some of the tissue maybe included in an envelope region (virtual 3D region) and potentially beinvolved in the solution (appliance or restoration). In thiscircumstance, some portion of the patient's tissue may be modified,using, for example surgery. In one embodiment, an envelope regionincludes tissue that can be included in the movement profile developmentand calculation. A given arch may have a circumstance that the tissue ofthe arch may not be modified but can be included in the movement profiledevelopment and calculation. A given arch may have a circumstance thatthe tissue of the arch may be modified and must be included in themovement profile development and calculation. In a circumstance that theto-be-modified tissue in an arch should be involved with the movementprofile development and calculation, an envelope region must be definedvirtually (e.g., by applying planar curves or by placing a virtualretentive piece) in a location far enough into the tissue of that archto include all parameterizations of the movement and stop profile andany potential retentive pieces the clinician intends to evaluate. In acircumstance that the not to be modified tissue in an arch should beinvolved with the movement profile development and calculation, anenvelope region (3D region) must be defined to include the guidance sidesurface contact data of that arch. In either circumstance, the not to bemodified arch or the to-be-modified arch may also have additionalprosthetics or appliance(s) applied to achieve the correct movementprofile (only some of the space is available between the planar curvesthat may or may not also represent potential surfaces of potentialretentive pieces to be replaced by CAM produced appliances, orrestorations).

In the circumstances where the clinician intends to modify tissue (e.g.,alter a tooth) or utilize tissue within a solution, this space must beincluded within an envelope region (3D region) for the guidance packagecalculation. Further this space must be included in parametricalcalculations to further refine the shape of guidance and stop profilesand any desired retentive pieces.

Therefore, if planar curve(s) are used to define a 3D region (enveloperegion), for the purpose of calculation on the arch or arches leftunmodified, the planar curves can be placed virtually into the tissue ofthe arch far enough past the guidance side surface of the arch toinclude all contact information of that arch, thus making the contactinformation available for calculation and development of the movementand stop profile and any desired retentive piece. Similarly, for thepurpose of calculation on the arch or arches to be modified, a virtualplanar curve can be placed virtually into the tissue of that arch farenough past the guidance side surface of the arch to anticipate anypotential guidance package derived modifications of that arch that theclinician intends to evaluate (e.g., to include areas that may bemodified within a 3D region).

Examples are illustrated in FIGS. 31A-31E. In some circumstances, aglobal 3D region in which the space for all guidance package systemparameterization (e.g., retentive piece(s), guidance package, andsurgical, restorative, and implant placement guides) may be utilized.For example, planar curves or a tissue side surface 710 of a virtualretentive piece may provide boundaries to a global 3D region. In somecases, a subset of the global 3D space may be considered. For example,limited virtual 3D regions may also be defined and utilized for subsetparameterizations of retentive pieces and/or guidance and stop packagefeatures, and/or surgical, restorative, implant placement guides and/orother considerations.

FIG. 31A illustrates two dentate arches 3110 a in which the clinicianintends to modify the tissue of both arches. Each respective virtualcurve of the guidance side surface of a potential retentive piece 3120 ais virtually located far enough into the tissue 3130 a past the guidanceside surface of its respective arch defining an envelope region (3Dregion) 3145 a in 3140 a in order to anticipate and later generate theparameterizations of the movement profile (and therefore the potentialguidance package derived modifications of those arches) the clinicianintends to evaluate. In this circumstance the clinician may generateguidance package derived restorative guides (for example, as illustratedin FIG. 35E) to modify those teeth with adjustments, crowns, bridges,removable partial dentures or other prosthetics that have guidance andstops derived from the guidance package system.

FIG. 31B illustrates with two edentulous arches 3110 b in which theclinician intends to modify the tissue of both arches. Each respectivevirtual curve of a guidance side surface of a potential retentive piece3120 b is virtually located far enough into the tissue 3130 b past theguidance side surface of its respective arch defining an envelope region3145 b in 3140 b in order to anticipate and later generate theparameterizations of the movement profile (and therefore the potentialguidance package derived modifications of those arches) the clinicianintends to evaluate. In this circumstance, the clinician may generateguidance package derived surgical guides (for example, as illustrated inFIG. 35F) to modify those tissues using surgery and other techniques toadd or remove tissue. Using the information from the guidance packagesystem with the virtual curves of the potential retentive pieces inthese locations can produce implant placement surgical guides (forexample, as illustrated in FIG. 35G) that enable the clinician to placeimplants at angulations indicated understanding the forces of occlusion.

FIG. 31C illustrates a dentate arch opposing an edentulous arch 3110 c.In this example, the clinician places the virtual curve of a guidanceside of the potential virtual retentive piece 3120 c on the dentate archinto the tissue past the guidance surface of 3130 c, and places thevirtual curve of the guidance side surface of the virtual retentivepiece 3120 c on the guidance surface of the edentulous arch 3130 c. Inthis case, an envelope region 3145 c, as shown in 3140 c, is defined bythe guidance surface of the retentive piece virtually placed on theedentulous arch and the planar curve embedded into the tissue of thedentate arch in order to anticipate and later generate theparameterizations of the movement profile (and therefore the potentialguidance package derived modifications of the dentate arch) theclinician intends to evaluate. A guidance package solution may include aderived restorative guide and a guidance equipped retentive piece. Theguidance package equipped printed mandibular retentive piece may involvea different 3D region that includes both the calculation andparameterization of the retentive piece and calculation andparameterization of the guidance package features to be combined withthat retentive piece. The physical retentive piece may utilize implantsas the attachment mechanism to the tissue of the mandibular arch.

FIG. 31D illustrates a dentate arch 3110 d with a potential virtualretentive piece 3120 d placed thereon into the tissue 3130 d, andutilizes the virtual curve of the tissue side surface 3140 c to define aboundary of a 3D space for parameterization.

FIG. 31E illustrates an edentulous arch opposing a dentate arch 3110 e.In this example, the clinician places a boundary of a 3D region usingcurves 3120 e past the tissue 3130 e of the arches, to define a 3D space3145 e without the use of virtual retentive pieces 3140 e.

In some circumstances, the clinician may produce, from the parametricdetermination made of guidance and stops from an envelope of parametricchoices, a restorative guide or stent to modify the dentate arch usingadjustments, crowns, bridges or other prosthetics and also a printedopposing corollary restoration for the edentulous arch. All the surfaces(of the adjusted teeth or tissue, or not adjusted teeth or tissue andprosthetics of the modified arch and all the surfaces of the printedcorollary restoration for the edentulous arch) of guidance and stops andretentive piece(s) can be derived from or included in the parametricalcalculation of the guidance package system.

In some circumstances, an envelope region (virtual 3D region) formathematical manipulation of the shape of the guidance profile andretentive piece(s) does not involve any tissue, may include only contactsurface data of the arch, or may include the tissue past the guidanceside surface of that arch. Accordingly, parameterizations of themovement profile (and therefore the potential guidance package derivedmodifications of that arch) the clinician intends to evaluate mayinclude tissue, include only a surface of the tissue, or exclude alltissue from a given arch. On any given arch, an operator may provide,based on this data, appliances, restorations, restorative guides,surgical guides, and/or implant placement guides.

One of ordinary skill will understand that the dentate arch and theedentulous arch may be either a mandibular arch or a maxillary arch. Itwill also be understood that the examples in FIGS. 31A-E arenon-limiting, and an envelope region may be variously defined to includeor exclude various portions of tissue or tissue guidance side surfaces.

FIG. 32 is a flowchart of a method 3200 in accordance with someembodiments of the present disclosure. An appropriate index position ofthe mandible in relation to the maxilla for a particular patient for aparticular solution (e.g., a prescribed maximum closure position) isidentified 3210. The appropriate canonical guidance package (movementand stop profile) for the solution is specified 3220. The canonicalguidance package may be a virtual representation and/or a mathematicalobject. Using patient specific data (or average, generic, or other data)the canonical guidance package is sized, indexed into position,adjusted, and attached. A 3D region is defined 3230 within the model.For example, curves defining boundaries of the 3D region (e.g., planarcurves, surfaces of retentive pieces, tissue surfaces, or internalportions of the surfaces) may be established, and a geometric shape ofan arch form that comports to that patient's skeletal frame of maxillaand mandible is formed between the virtual curves of the retentivepieces at the prescribed index position. It will be understood that the3D region and its boundaries may be determined at different times (e.g.before or after application of the guidance package and before or afteridentifying the index position) and in various manners. Finally, themethod includes parameterizing 3240 the guidance package and/oradditional guidance solution functions (e.g., retentive pieces orrestorative guides) within a 3D region to establish one or moresolutions for implementing a customized guidance profile of thepatient's mandible.

FIG. 33 illustrates an example application of the method discussed withreference to FIG. 32 . In 3300-a FIG. 33 , an index position isidentified (3210). 3300-b illustrates a guidance package 3325 (“GP”)virtually applied (3220) to define a desired movement. The guidancepackage may be applied as, for example, a geometric object or amathematical description of movement. 3300-c illustrates an enveloperegion (3D region) 3335 being defined (3230). For example, bounds of theenvelope region may be set based on an application of one or morevirtual retentive pieces or surfaces of retentive pieces, although thisis merely an example. In some cases, the bounds of an envelope regionmay include the surface of tissue (e.g., teeth), or extend into tissue.For example, a geometric shape of an arch form that comports to thatpatient's skeletal frame of maxilla and mandible is formed between thesurfaces of virtual retentive pieces at the prescribed index position.

3300-d illustrates that a customized guidance and stop profile isdeveloped from within the envelope region 3335. This may be accomplishedby parameterizing (3240) the applied guidance package and/or theretentive pieces within the envelope region. By parameterizing thespace, an envelope within which the areas, volumes, and the topographyof the contact surfaces of the guidance and stop components can now bechanged in concert with each other in a way that maintains thecustomized movement and stop profile derived from the indexed, sized,adjusted and attached appropriate guidance package. This can form thedesired appliances and restorations. According to some embodiments, anyguidance or other mechanisms (e.g., implants, retention pieces, tissuesurfaces) of the final solution must fall within the bounds of anenvelope region. In some cases, the guidance surfaces of the finalsolution must fall within the bounds of an envelope region.

FIG. 34 illustrates visual representations of five guidance and stopprofiles (guidance packages). Canine Guidance 3410 and Group FunctionGuidance 3420 packages are movement and stop profiles that are oftenexpressed in the teeth and arches of the stomatognathic systems of thehuman population. It has been observed and noted by dentists that theseguidance and stop patterns can provide to that particular person“normal” or “ideal” guidance and function in the context of theneuromuscular system of the stomatognathic system. Bilateral anteriorrepositioning 3430, Asymmetric 3440, and Asymmetric protrusive 3450guidance packages are movement and stop profiles that are generally notexpressed in the stomatognathic systems of human beings. These guidanceand stop profiles may be applied to provide therapeutic scenarios offunction to include sleep apnea and TMD. These movement and stopprofiles have been observed and noted by dentists to provide successfultherapies (e.g., TMD and sleep apnea) in the context of theneuromuscular system of the stomatognathic system. The physicalrepresentations of FIG. 34 are for explanation purposes only. In somecases, these guidance and stop profiles may be virtually represented andapplied to a virtual articulator.

One of ordinary skill will understand that motion defined by guidanceand stop profiles (e.g., 3410-3450) may be represented as geometric ormathematical functions, which may be applied to a virtual representationof a patient's arches. In both situations, the guidance and stopprofiles may only define requirements of ultimate solutions (e.g., apath that must be followed), but not define the ultimate solutions(e.g., whether the solution includes one or more of a restorative guide,a surgical guide, a retentive piece, or tissue surfaces). For example,the customized movement profile may be understood as a mathematicalobject and a 3D region (envelope region) available for manipulation ofthe mathematical object, a continuum within this envelope of otherparameterized synergistic shapes (e.g., shapes that work together toguide the mandible along the prescribed path) can be mathematicallyderived that will allow final product considerations and other patientconsiderations.

From the continuum of parametrical possibilities a clinician may producemany different one or two arch solutions as shown in FIGS. 35A-35G. FIG.35A illustrates a solution with two-arch retentive pieces 10 inaccordance with various embodiments of the present disclosure. In thiscase, surfaces of the retentive pieces 10 are designed to interact inguiding the mandible to the index position. In some circumstances, atwo-arch solution can be used to treat bruxism, TMD, sleep apnea, andother conditions. FIG. 35B illustrates a solution with two-archrestoration in accordance with various embodiments of the presentdisclosure. The restorations may include dentures, modified naturalteeth or other tissue, unmodified natural teeth or other tissue, crowns,bridges, removable partial dentures, other fixed prosthetics, otherremovable prosthetics, and combinations thereof. In the two-archrestoration, the surfaces of the various components (e.g., dentures,artificial teeth, and natural teeth) are designed to interact to guidethe mandible into the index position. FIG. 35C illustrates solutionswith one-arch retentive piece 10 in accordance with various embodimentsof the present disclosure. In this case, surfaces of the retentive piece10 are designed to interact with tissue surfaces on the opposing arch inguiding the mandible to the index position. FIG. 35D illustratessolutions with one-arch restoration in accordance with variousembodiments of the present disclosure. In the one-arch restorations, thesurfaces of the various components (e.g., dentures, artificial teeth,and natural teeth) are designed to interact with the tissue in theopposing arch to guide the mandible into the index position.

FIGS. 35E-35G illustrate a guidance package derived restorative guideFIG. 35E, a surgical guide FIG. 35F, and an implant placement guide FIG.35G in accordance with an example embodiment of the present disclosure.Surgical guides FIG. 35F could include major arch shape changestents/guides for a surgeon to aid in the manipulation of bone, sinus,gum and other tissues of the arch, or more conservatively a custom fullarch restorative guide FIG. 35E with breaks or openings to indicateadjustment points for existing dentition or prosthetics. A restorativeguide FIG. 35E can be used in the case where a clinician may want tomodify the arch form to be consistent to a guidance package solution toinclude teeth, and/or other tissue, and/or existing prosthetics. Asurgical guide FIG. 35F can be used in the case where a clinician maywant to surgically modify the arch form to be consistent to a guidancepackage solution to include teeth, and/or bone, and/or gum, and/or othertissue, and/or existing prosthetics. For example, one of these classesof material, e.g., bone, may be modified, e.g., the mandible ismodified, such that the resulting shape of that arch allows theapplication of the determined parameterization. An implant placementguide FIG. 35G can be used in the case where a clinician may want toplace implants at appropriate angulations according to the arch formaccording to a guidance package solution to include one or both arches.For example, it may be desirable to use an implant placement guide tocreate the appropriate angles of implant placement for a specific curveof Spee and Wilson, respectively or relative to the angles of occlusion(See, e.g., FIGS. 44A-44B).

FIGS. 36A and 36B illustrate example final solutions where a canonicalcanine guidance package (e.g., 3410 of FIG. 34 ) in accordance with someembodiments of the present disclosure is applied, for example, using themethod described with reference to FIGS. 32 and 33 . Referring to both36A and 36B, boundaries of an envelope region can be defined, the indexposition may be identified (e.g., a centric relation at appropriatevertical dimensions), the canonical canine guidance package iscustomized for the patient (sized, indexed, adjusted, and positionedvirtually), creating a customized movement and stop profile. This may beconsidered, for example, a geometrical object. An envelope region may bedefined by the available space between the boundaries, and thencustomized movement and stop profile can be parameterized within theenvelope region to create solutions. In some cases, the form of thesolution may be based on whether the arches are dentulous, edentulous,or partially edentulous. In some cases, a form of solution may beselectable, for example, by a dentist or clinician or operator of thesystem. It will be understood that the final solution may be, forexample, an appliance solution, arch reconstruction, restoration,rehabilitation, and/or optimization, or some combination of theproceeding.

Referring to FIG. 36A, in a case where both mandible and maxilla aredentulous, partially edentulous or other, the parameterization mayresult in one or more designs for a two-piece appliance. Each appliancepiece could be inserted over a corresponding arch and the surfaces ofthe appliances would interact to control the customized movement andstop profile. For example, 3600 a-1 and 3600 a-2 illustrate two possiblecustomized solutions. In 3600 a-1, the two-piece appliance ischaracterized by guidance located in the canine areas. In comparison,3600 a-2 is characterized by guidance centered in the canine areas ofthe retentive pieces with broader contact areas. One of ordinary skillwill recognize that 3600 a-1 and 3600 a-2 represent just two examplesfrom within a parametrical continuum of different shapes that wouldcontrol a same customized guidance and stop profile to the indexposition for the patient. The final appliances may be smoothly flowingplastic (or other material) shapes that have a certain geometry toinclude the contact surfaces (guidance and stops) that may appear verydifferent from the canonical canine guidance package, but with shapesdetermined from within an envelope of possibilities mathematicallyderived from the sized, indexed, adjusted and attached canine guidancepackage and will feature the same movement and stop profile.

Referring to FIG. 36B, in a case where both mandible and maxilla areedentulous, the parameterization may result in one or more designs for atwo-piece restoration. These guidance package derived restorations mayserve to guide the patient's mandible utilizing the surfaces of thereplacement dentition (i.e., the false teeth) to interact to control thecustomized movement and stop profile. The edentulous circumstance (FIG.36B) may provide a greater envelope region than the dentulous (FIG.36A), as the natural teeth would not serve as a barrier. As non-limitingexamples of edentulous solutions, 3600 b-1 and 3600 b-2 illustrate twopossible customized solutions. In 3600 b-1, the two-piece restoration ischaracterized by a certain complement of stops (dots) and guidance(shading) located on the prosthetic teeth and angulations of theprosthetic teeth to perform the guidance. In comparison, 3600 b-2 ischaracterized by a different complement of stops and guidance located onthe prosthetic teeth and angulations of the prosthetic teeth to performthe guidance. For example, if the index position is centric relation atan appropriate vertical dimension, the stops, guidance, and angulationsmay be consistent with ideal canine guidance. One of ordinary skill willrecognize that 3600 b-1 and 3600 b-2 represent just two examples fromwithin a parametrical continuum of virtual morphing shapes of dentatearches in synergy that would control a same customized guidance and stopprofile to the index position for the patient. The final restoration(s)may be of materials that mimic patient tissue in certain geometricshapes to provide the same movement and stop profile as derived from thesized, indexed, adjusted and attached canine guidance package. Themimicked tissue can include very different shapes from the canonicalcanine guidance package, but the shapes are chosen from within anenvelope of possibilities of canine guidance restorative choicesmathematically derived from that guidance package to feature that samemovement and stop profile.

It will be understood that the stomatognathic system includes aneuromuscular system. In some cases, neuromuscular considerations shouldbe included when considering different parameterizations (e.g.,solutions) of a movement and stop profile for either an appliance or arestoration. It the context of the stomatognathic system, differentsynergistic shapes of the same movement profile may produce differentresponses from the neuromuscular system. For example, the neuromuscularsystem reacts differently for stress placed on the posterior teeth ascompared to stress placed on anterior teeth, and, therefore, may reactdifferently to guides and stops anchored near the posterior teeth ascompared guides and stops anchored anteriorly. An operator may usedifferent parameterizations of the same movement and stop profile toutilize different areas of the arches for guidance and stops to providedifferent neuromuscular responses. These considerations may be includedin the customization of the guidance package before or afterparameterization. Using a system or method according to the presentdisclosure may therefore provide greater flexibility and range ofoptions over the related art. Neuromuscular considerations may influencea selection of parameterization for various guidance profiles bothdisclosed herein and as would be known by one of ordinary skill.

FIGS. 37A and 37B illustrate example final solutions where a canonicalgroup function guidance package (e.g., 3420 of FIG. 34 ) in accordancewith some embodiments of the present disclosure is applied, for example,using the method described with reference to FIGS. 32 and 33 . Themethod may be implemented substantially similar to that described abovewith Reference to FIGS. 36A and 36B, and thus a description will not berepeated here for compactness. It will be understood that the finalsolution may be, for example, an appliance solution, archreconstruction, restoration, rehabilitation, and/or optimization, orsome combination of the proceeding.

Referring to FIG. 37A, in a case where both mandible and maxilla aredentulous, partially edentulous, or other, the parameterization mayresult in one or more designs for a two-piece appliance (e.g., atwo-piece bruxism appliance). Each appliance piece could be insertedover a corresponding arch and the surfaces of the appliances wouldinteract to control the customized movement and stop profile. Forexample, 3700 a-1 and 3700 a-2 illustrate two possible customizedsolutions within a parametrical continuum of different shapes that wouldcontrol a same customized guidance and stop profile to the indexposition for the patient. In 3700 a-1, the two-piece appliance ischaracterized by guidance located primarily in the midline. Incomparison, 3700 a-2 is characterized by guidance that extends furtherinto the posterior areas of the appliance. The clinician may considerneuromuscular implications of different parameterizations when making adetermination. The final appliances may be smoothly flowing plastic (orother material) shapes that have a certain geometry to include thecontact surfaces (guidance and stops) that may appear very differentfrom the canonical group function guidance package, but with shapesdetermined from within an envelope of possibilities mathematicallyderived from the sized, indexed, adjusted and attached group functionguidance package and will feature the same movement and stop profile.

Referring to FIG. 37B, in a case where both mandible and maxilla areedentulous, the parameterization may result in one or more designs for atwo-piece restoration. The guidance package designed restorations mayserve to guide a patient's mandible to the index position using surfacesof the replacement dentition (i.e., the false teeth) to interact tocontrol the customized movement and stop profile. As non-limitingexamples of edentulous solutions, 3700 b-1 and 3700 b-2 illustrate twopossible customized solutions within a parametrical continuum of virtualmorphing shapes of dentate arches in synergy that would control a samecustomized guidance and stop profile. In 3700 b-1, the two-piecerestoration is characterized by a certain complement of stops (dots) andguidance (shading) located on the prosthetic teeth and angulations ofthe prosthetic teeth to perform the guidance consistent with thecustomized profile. Meanwhile, 3700 b-2 is characterized by a differentcomplement of stops and guidance located on the prosthetic teeth andangulations of the prosthetic teeth to perform the guidance. Forexample, the stops, guidance, and angulations may be consistent withideal group function guidance. The final restoration(s) may be ofmaterials that mimic patient tissue in certain geometric shapes toprovide the same movement and stop profile as derived from the sized,indexed, adjusted and attached group function guidance package. Themimicked tissue can include very different shapes from the canonicalgroup function guidance package, but the shapes are chosen from withinan envelope of possibilities of group function guidance restorativechoices mathematically derived from that guidance package to featurethat same movement and stop profile.

FIGS. 38A and 38B illustrate example final solutions where an asymmetricguidance package (e.g., 3440 of FIG. 34 ) in accordance with someembodiments of the present disclosure is applied, for example, using themethod described with reference to FIGS. 32 and 33 . In one example, atwo piece TMD (TMJ Dysfunction) appliance may be planned for a dentatepatient, and the index position may be the prescribed respectiveasymmetric index positions for that particular patient and thatparticular purpose. A canonical asymmetric guidance package iscustomized (e.g., sized, indexed, adjusted, and attached) to theretentive pieces, such that it is now customized for that patients' dataand can be defined as a geometrical object. The data for this particularpatient could include specific TMD (TMJ dysfunction) data. This datacould be collected through the use of clinical evaluation, 3D x-ray, aJaw Motion Analyzer (e.g., as illustrated in FIG. 14 ), or othermethods. This data could influence envelope region(s) and theparameterizations within that (those) envelope region(s). For a givenTMD patient, certain movements and stops may be favored or avoided basedon the particular TMD malady of that particular patient. Because theretentive pieces are placed on the dentate arches in the prescribedasymmetric orientation, the defined space (envelope region) may be verydifferent as compared to the previous examples.

Understanding the customized movement profile as a mathematical objectand the defined space (envelope region) available for manipulation, acontinuum within this envelope of other parameterized synergistic shapescan be mathematically derived that will allow other patientconsiderations. As non-limiting examples of dentulous, partiallyedentulous and other solutions, FIGS. 38A and 38B illustrate twopossible customized solutions within this continuum of synergistic,interacting shapes and contact areas that were derived from thecustomized guidance profile, which was in turn derived from anasymmetric guidance package. FIG. 38A illustrates front (3800 a-1) andlateral views (3800 a-2) of an asymmetric TMD treatment appliance inwhich the guidance is located on the posterior lateral or posteriorfacial aspects of the retentive pieces. Meanwhile, FIG. 38B illustratesfront (3800 b-1) and lateral views (3800B-2) views of an asymmetric TMDtreatment appliance in which the guidance is located in the anteriorarea of the retentive pieces. As with the other examples, the shapes ofthe contact surfaces may not appear to be the same as those of thecanonical asymmetric guidance package, but were chosen from within anenvelope of possibilities mathematically derived from the customizedasymmetric guidance package to feature that same movement and stopprofile. In some cases, such as for a rare asymmetric restoration, anasymmetric restoration can include materials that mimic patient tissuein certain geometric shapes to contribute to the movement and stopprofile (e.g., prosthetic teeth that feature inclinations and geometryof the teeth surfaces and angles and inclinations of the teeth cusps).

FIGS. 39A and 39B illustrate example final solutions where a bilateralanterior repositioning guidance package (e.g., 3430 of FIG. 34 ) inaccordance with some embodiments of the present disclosure is applied,for example, using the method described with reference to FIGS. 32 and33 . Potential uses of a bilateral anterior repositioning guidancepackage (that may be a virtual representation and/or a mathematicalobject) in accordance with an example embodiment of the presentdisclosure include TMD appliances, other appliances, a series of steptherapeutic appliances for rehabilitation (e.g., for displaced meniscusdiscs), sleep apnea appliances (e.g., by bringing the jaw forward in theindex position), symmetrical protrusive arch reconstruction (which islikely to be a rare), restoration, rehabilitation, and/or optimization.

As an example, a clinician may plan a bilateral anterior repositioningtwo arch sleep apnea appliance. As non-limiting examples of dentulous,partially edentulous and other solutions, FIGS. 39A and 39B illustratetwo possible customized solutions from within an envelope ofsynergistic, interacting shapes and contact areas that were derived fromthe customized guidance profile, which was in turn derived from abilateral anterior repositioning guidance package. FIG. 39A illustratesfront (3900 a-1) and lateral views (3900 a-2) of a symmetric protrusivesleep apnea appliance in which the guidance is located on the posteriorlateral or posterior facial aspects of the retentive pieces. Meanwhile,FIG. 39B illustrates front (3900 b-1) and lateral views (3900 b-2) of asymmetrical protrusive sleep apnea appliance in which the guidance islocated in the anterior area of the retentive pieces.

Another example of an appliance that could be derived from a bilateralanterior repositioning guidance package (3430 of FIG. 34 ) according tothe present disclosure would be a bilateral anterior repositioningappliance to treat bilateral anterior disc displacement of both TMJs. Inthis case, the same protocol would be used except that the prescribedindex position (maximum closure position) would be consistent with thepatient arches in a position therapeutic to treat a bilateral anteriordisc displacement of both TMJs in a patient, and the data for thisparticular patient could include specific TMD (TMJ dysfunction) data.This data could be collected through the use of clinical evaluation, 3Dx-ray, a Jaw Motion Analyzer (e.g., as illustrated in FIG. 14 ),sonography, MRI, or other methods. This data could affect enveloperegion(s) and the parameterizations within that (those) enveloperegion(s). For a TMD patient there could be areas of both movement andstops that may be favored or avoided based on the particular TMD maladyof that particular patient. This different appliance derived from a samecanonical bilateral anterior repositioning guidance package illustratesthe flexibility of the guidance package system to treat a wide varietyof ailments and situations, often with the same guidance package.

FIGS. 40A and 40B illustrate example final solutions where an asymmetricprotrusive guidance package (3450 of FIG. 34 ) in accordance with someembodiments of the present disclosure is applied, for example, using themethod described with reference to FIGS. 32 and 33 . Potential uses ofan asymmetric protrusive guidance package include TMD appliances,unilateral anterior repositioning appliances, other appliances, a seriesof step therapeutic appliances for rehabilitation, appliances forasymmetric protrusive arch reconstruction (rare), restoration,rehabilitation, and/or optimization. A canonical asymmetric protrusiveguidance package is customized (sized, indexed, and adjusted), andattached (for example to retentive pieces), such that it is nowcustomized for that patients' data and can be defined as a geometricalobject.

Data for this particular patient could include specific TMD (TMJdysfunction) data. As discussed above, this data could affect enveloperegion(s) and the parameterizations within that (those) enveloperegion(s).

As an example, a clinician may plan a two arch TMD appliance. Asnon-limiting examples of dentulous, partially edentulous and othersolutions, FIGS. 40A and 40B illustrate two possible customizedsolutions from within this continuum of synergistic, interacting shapesand contact areas that were derived from the customized guidanceprofile, which was in turn derived from an asymmetric protrusiveguidance package (3450 of FIG. 34 ). FIG. 40A illustrates a front viewof an asymmetric protrusive appliance in which the majority of theguidance is located on the posterior lateral or posterior facial aspectsof the retentive piece. Meanwhile, FIG. 40B illustrates a front view ofan asymmetric protrusive appliance in which the majority of the guidanceis located in the anterior area of the retentive pieces. As discussedabove with reference to other examples, the specific shape may differfrom the canonical guide, but will control a same movement and stopprofile.

In many of the previous examples the guidance package system has beenused to create two arches of guidance and stops working in synergy witheach other to provide the appliances or restorations that provide thenew movement profile to the new index position (prescribed maximumclosure position). The guidance package systems can also provide thetools to produce one arch solutions to be combined with the patient'sexisting, unmodified opposing arch to provide the new movement profileto the new index position. After the continuum of shapes is determined,the one-arch solution to be created will be evaluated by the cliniciansuch that when the created arch is combined with the patient'sunmodified opposing arch the prescribed movement profile to the newindex position (prescribed maximum closure position) is provided.

In some cases, retentive pieces are mounted virtually and then combinedwith the guidance and stop features. Then, after printing, the retentivepieces may be physically connected to the surface of the patient'stissue of that respective arch. In other embodiments, the retentivepieces or other guidance solutions are developed within a globalenvelope region defined by planar curves.

In some cases, a guidance package system according to the presentdisclosure (e.g., a CAD-CAM guidance package system) can provide thetools to consider existing tissue, not to be modified for a solution(e.g., use the naturally occurring guidance or stop features on thesurface of teeth and other tissues to adjust an index position or guidepath). In some embodiments, the guidance package system can also enablea clinician to consider existing tissue for manipulation/modification inconsideration of a particular guidance package solution.

In some embodiments, the retentive pieces may be virtualized and placedinto the tissue for consideration as part of the solution. An enveloperegion for parametrical calculation can be defined in many ways; in thisexample the retentive pieces and/or surfaces of retentive pieces may bevirtualized for that purpose.

In some embodiments, a 3D region may be defined by virtual curves. Thesecurves may or may not be associated with anatomical features, virtualretentive pieces, tissue, or many other considerations of how to includeor portion 3D regions.

FIG. 41 illustrates an example final solution where a canine guidancepackage (3410 of FIG. 34 ) in accordance with some embodiments of thepresent disclosure is applied, for example, using the method describedwith reference to FIGS. 32 and 33 . In FIG. 41 , the final solutiontakes the form of a one-piece (one arch) appliance (e.g., bruxismappliance) on a dentate patient with a major interference in themaxillary arch using a canonical canine guidance package (3410 of FIG.34 ) (that may be a virtual representation and/or a mathematicalobject), in accordance with an example embodiment of the presentdisclosure. In this example, a canonical canine guidance package is usedto produce a one arch canine guidance appliance that interacts with thispatient's unmodified maxillary arch to provide a canine guidancemovement profile to the designated index position (e.g., prescribedmaximum closure position). In this case, the boundaries of the enveloperegion would be the contact surfaces of one arch (e.g., a virtual curvepositioned to expose a surface of the one arch) and an appliancedisposed on the other arch (e.g., a virtual retentive piece whoseinferior surface exhibits the region defining curve virtually positionedon the other arch). As seen in 4100-a, the patient has a majorinterference 4110 in the tooth #3 (according to the Universal NumberingSystem a/k/a the American System) area of the maxillary arch. Due to themajor interference 4110, possibilities of acceptable opposing (one) archappliances will likely come from within a narrow continuum. That is, anysolution must provide canine guidance in the context of this unmodifiedmaxillary arch that includes a major interference.

Once the canonical canine guidance package is customized andappropriately attached, this now customized for that patient movementprofile can be defined as a geometrical object. As a non-limitingexample, 4100-b is a one arch mandibular appliance selected from withina continuum of possibilities mathematically derived from the canineguidance package that feature the same movement and stop profile. Inthis example, the one arch appliance 4100-b features thin material onthe mandibular retentive piece in the area (4120) opposing the maxillaryarch interference (tooth #3) and strong canine guidance in the caninearea (4130) of the mandibular retentive piece to guide over that majormaxillary (#3) interference. The surface of the mandibular retentivepiece is shaped to interact with the surface of the tissue of themaxillary arch (e.g., teeth). Although the shape of the mandibularretentive piece may differ from the customized canonical guidancepackage, but will feature the same movement and stop profile.

FIG. 42 illustrates another example final solution where a canineguidance package (3410 of FIG. 34 ) in accordance with some embodimentsof the present disclosure is applied, for example, using the methoddescribed with reference to FIGS. 32 and 33 . In FIG. 41 , the finalsolution takes the form of a one-piece (one arch) restoration on apatient who is dentate on the maxillary arch with a major interferenceand an edentulous mandibular arch. This formation is similar to theexample described above with reference to FIG. 41 , except the patient'smandibular arch is edentulous and the final solution takes the form of arestoration.

Referring to FIG. 42 , the final solution takes the form of a one archmandibular restoration 4200. In this example, the printed restorationfeatures very thin material (a very small prosthetic tooth (4220) on themandibular restoration opposing the maxillary interference and strongcanine guidance on the mandibular restoration in the form of prostheticteeth at the correct angulations on the canine areas (4230) of theretentive piece to guide over that major maxillary (#3) interference.The inclinations and geometry of the prosthetic teeth, including theangles and inclinations of cusps and other features, may provide theguidance and stops via interaction with the unmodified maxillary arch.

In many of the examples above, the guidance package system according tosome embodiments of the present disclosure have been used in thecreation of two piece appliance systems, two piece restorative systems,one piece appliance systems, and one piece restorative systems that canguide a patients mandible by a prescribed 3D route (dependent upon theguidance package used) to a prescribed index position (e.g., prescribedmaximum closure position). In some circumstances, however, it may bebeneficial to adjust the shape and size of one or both arches of thepatient, which may otherwise be incompatible with a desired guidancepackage solution. According to some embodiments of the presentdisclosure, the clinician in thesurgical/restorative/reconstructive/optimizing work that may need tooccur on an arch or arches of a patient to change the shape, size,volume, contact area topography and other aspects of an arch in the formthat will be compatible with the desired guidance package solution. Incertain circumstances, a patient's existing tissue may make theapplication of certain solutions either uncomfortable, or not reasonablyfeasible (for example, multiple excessively large interferences).

Accordingly, some embodiments of the present disclosure may providetools for producing surgical or restorative guides (see, e.g., 35E-F).These guides can indicate areas to remove tissue or to add tissue. Insome cases, it may be advantageous to utilize a conservative treatmentplan to one arch (e.g., retentive piece) that enables minimaladjustments to the opposing arch. The envelope of parametricalpossibilities enables a clinician to evaluate both arches simultaneousregarding shape and evaluate to find conservative two arch approaches.In some cases, the guidance package system may be configured to identifyconservative approaches based on an amount of tissue added or removed,or a number of areas where tissue is to be added and removed. In somecases, a clinician may choose a guidance package derived restorativeguide for a dentate arch that allows him conservative adjustment of thedentate arch to enable him to plan for the printed opposing arch heprefers in the context of the overall guidance package solution.

For example, FIGS. 43A and 43B illustrate final solutions taking theform of a two-arch modification and restorative solution on a patientwho is dentate on the maxillary arch with a major interference opposingan edentulous mandibular arch using a canonical canine guidance package,in accordance with an example embodiment of the present disclosure. Thissituation may be identical to that described with reference to FIG. 42 ,except that the desired solution differs. Accordingly, the boundary forthe envelope region will extend into the tissue of the maxillary arch.In some embodiments, this is accomplished by placing a virtual curvewithin the tissue of the maxillary arch. This patient has a majorinterference in the maxillary arch #3 tooth area as well as some minorinterferences of the maxillary arch as defined by the two-arch canineguidance package solution the clinician has determined.

Referring to FIG. 43A, the canine guidance package derived restorativeguide 4300 a-1 may be used on the maxillary arch for reducinginterferences (i.e., may guide a dentist, dental surgeon, or oralsurgeon in reducing the interference or otherwise altering the tissue ofthe maxillary arch). 4300 a-2 illustrates the maxillary arch beforeinterference reduction and 4300 a-3 illustrates the maxillary arch afterinterference reduction. The opposing mandibular produced arch (4300 b-1or 4300 b-2) that will be applied to the patient's edentulous mandibulararch may be formed to interact with the maxillary arch as modifiedaccording to the restorative guide 4300 a-1 in to provide the prescribedmovement profile to the new prescribed index position (prescribedmaximum closure position). As will be understood, the restorative guide4300 a-1 and the opposing mandibular arch (4300 b-1 or 4300 b-2) arejust example solutions from a continuum of mathematically derivedpossibilities.

In some cases, a desired restorative guide 4300 a-1 may first beselected, and then a compatible arch restoration (e.g., 4300 b-1 or 4300b-2) may be selected from a continuum of mathematically derivedpossibilities. In some cases, a desired arch restoration (e.g., 4300 b-1or 4300 b-2) may be selected and the compatible restorative guide 4300a-1 may be selected from a continuum of mathematically derivedpossibilities. In some cases, a single restorative guide 4300 a-1 may beused to adjust the arch. In other cases, two or more restorative guidesmay be designed and printed to guide in two or more procedures. In theexample discussed with reference to FIGS. 43A and 43B, parametricconsiderations (e.g., possible solutions) include surgical/restorativeguides or stents for modifying the maxillary arch along with formed,printed, or CAM-produced opposing arch corollaries. A two archrestorative solution is determined from a continuum of shapes. In thisexample, the shape possibilities could include those that, whenconservative changes are accomplished on the maxillary arch usingguidance package derived surgical/restorative guides or templates, acertain range of printed opposing full arch mandibular restorativechoices become available.

In some cases, a clinician may determine that shape changes of the archform of a patient may be needed because the patient's current archarchitecture does not function well with the parameters of theirparticular TMJ set. It is understood by many dentists that the curves ofocclusion, including the curve of Wilson FIG. 44B and the curve of SpeeFIG. 44A, are important to the health and function of both the teeth andthe TMJs. It is believed by many dentists that the mandibular teeth moveover the surface of the maxillary teeth as over the surface of a spherewith an approximate diameter of eight inches, the sphere of Monson FIG.44C. These curves allow the harmony of teeth and TMJs in function and inrest.

Regarding the curve of Spee FIG. 44A, it is the anatomic curveestablished by the occlusal alignment of the teeth or arch as projectedonto the median plane from the tip of the mandibular canine to themandibular condyle (4410A and 4420A). It is believed by many dentiststhat the anterior/posterior tilting of teeth (4430A and 4420A) enabledby the curve of Spee is appropriate to keep the individual teeth atright angles to the forces of occlusion. Some dentists regard the curveof Spee as an extension of the arc of closure. As an example, the curveof Spee combined with inclination of the canine surfaces (canine teeth)provides the guidance that provides for the appropriate disclusion ofthe posterior teeth in a protrusive excursion of the mandible.

Regarding the curve of Wilson FIG. 44B, it is the medio-lateralcurvature of the occlusal plane of the posterior teeth. Many dentistsbelieve the purpose of the arc or curve is to complement the paths ofcondyles during movements of the mandible. It is further understood thatthe increased heights of the mandibular buccal cusps (due to theirangulations provided by the curve of Wilson) and the complementary formof the upper posterior teeth (due to their angulations due to the curveof Wilson) cusps allow the food to remain in the chewing area and notspill out laterally.

Additional or alternative functions of the curves of occlusion inaddition to those listed above may include force accepting structure ofthe arch form (the curves of occlusion) that may be manipulated usingone or more embodiments of the present disclosure. The shape of thefinal restored arch using the guidance package system can produceprosthetic teeth and individual cusps of those prosthetic teeth inclinedin the image of the curves of Wilson and Spee (when combined is thesphere of Monson) (FIGS. 44A-44C), in a shape that brings harmony withthe TMJs (or other therapeutic goal).

The guidance package system can distribute guidance and stopsstrategically over any of the available surface area or a subset ofavailable surfaces to accommodate all the curves of occlusion (the“teeth” are in many ways the final extension of these curves). While theteeth themselves have a certain shape, their inclination is alsoimportant for guidance and accommodation of the curves of occlusion. Thecurves of occlusion or the “shape” of the arch is important. It is notjust the features of the teeth, but the inclination of those teeth inregard to each other. In certain embodiments, the guidance packagesystem can provide both the overall 3D shape of the arch form, and thefinal guidance and stop features (teeth) blended together. This is oneadvantage of certain embodiments, as the related art does not allowparametric considerations of that patient's particular TMJ set.

FIGS. 45A-45C will be referred to in developing solutions of a two-archmodification and restorative solution on a patient who is dentate on themaxillary arch with a major interference opposing an edentulousmandibular arch with an inappropriate tissue mass using a canonicalcanine guidance package (e.g., 3410 of FIG. 34 ) is applied, forexample, using the method described with reference to FIGS. 32 and 33 .In this example the patient has a dentate maxillary arch incompatible4510A (e.g., a major interference similar to that discussed above withreference to FIG. 41 ) with the two-arch solution desired. The patient'smandibular arch is edentulous and has a tissue mass 4520A that isincompatible with the two-arch solution desired. This patient's TMJvalues are considered in the solution to provide appropriate curves ofocclusion (FIGS. 43A-43C) to optimize occlusal/TMJ synergy. In thepresent example, the boundary of the envelope region will be defined toinclude tissue of the mandibular arch and the maxillary arch, forexample, by placing virtual curves beneath the surface of some portionof the maxillary and mandibular arches.

In some circumstances, the two-arch modification may modify themaxillary arch using a guidance package derived restorative guide. Insome circumstances, the two-arch modification may modify an edentulousmandibular arch by removing the inappropriate tissue mass using asurgical guide.

In some implementations, implants may be placed into the surgicallymodified mandibular arch at appropriate angulations based on the curvesof occlusion, provided by the guidance package system in the form ofrestorative and surgical guides, using a guidance package derivedimplant placement guide FIG. 35G. Using a guidance package derivedimplant placement guide will enable an operator to place implants atangulations appropriate to the curvatures and force vectors of theguidance package solution.

Referring to FIGS. 45A-45C, once the boundaries of the envelope regionare defined and the guidance package is attached (and/or customized),one or more restorative guides may be generated for the maxillary arch,and one or more surgical guides may be generated for the mandibular archto address the incompatible tissue. In addition, a mandibular implantplacement guide and mandibular restoration (e.g., false teeth) may bedesigned to interact with the tissue (e.g. teeth) of the maxillary archto provide the customized movement profile. FIGS. 45B and 45C illustratetwo possible solutions. In some embodiments the two arch solution may bedetermined not only based on an envelope region and guidance and stopprofile, but also to include the appropriate curves of occlusion for aparticular patient based on TMJ data (FIGS. 45B and 45C).

In some cases, the parameterization of a movement profile may enablegeneration of surgical and/or restorative guides to change an arch formbased on TMJ values (e.g., change to an ideal or near-ideal arch formbased on the TMJ value consistent with the curves of occlusion).

Movement and stop profile and parameterizations are a continuum ofvirtual (and mathematical) morphing shapes of the maxillary arch and themandibular arch in synergy with each other. This continuum ofpossibilities within the envelope region provides different areas ofcontact and guidance that may interact differently with thestomatognathic system but will allow an operator to maintain thedetermined movement and stop profile. Ultimately in this example thedentate maxillary arch will be modified using restorative guide(s) (toaddress the interference 4510A), the edentulous mandibular arch will bemodified with surgical guide(s) (to address the tissue 4520A) and animplant placement guide (to provide a base for a restoration and toaccommodate the curves of occlusion), and the mandibular arch will berestored with a printed mandibular arch restoration (for interactingwith the tissue of the modified maxillary arch). The final result willfeature the manipulated maxillary dentate arch (and perhaps #3 restoredusing a crown as a subset of the overall guidance package solution) anda surgically manipulated mandible with implants appropriately placed toattach to the retentive piece of the printed mandibular restoration(FIG. 45D). This comprehensive modification/restoration will feature theappropriate curves of occlusion (Spee and Wilson) and guidance and stopprofile determined by the clinician considering this particularpatients' therapeutic situation to include that patients' particular TMJvalues.

Referring to FIGS. 45A-45D, the final product will feature a guidancepackage derived modified maxillary arch, a surgically modifiedmandibular arch, implants placed in the mandibular arch using a guidancepackage derived implant placement guide, and a printed mandibularrestoration to be mounted on the previously placed implants. Thisguidance package derived modification/restorative solution will providethe same guidance and stop profile as the customized guidance package,and may also provide the appropriate curves of occlusion for thisparticular patient based on his TMJ data.

It is to be understood that the embodiments and claims disclosed hereinare not limited in their application to the details of construction andarrangement of the components set forth in the description andillustrated in the drawings. Rather, the description and the drawingsprovide examples of the embodiments envisioned. The embodiments andclaims disclosed herein are further capable of other embodiments and ofbeing practiced and carried out in various ways. Also, it is to beunderstood that the phraseology and terminology employed herein are forthe purposes of description and should not be regarded as limiting theclaims.

Accordingly, those skilled in the art will appreciate that theconception upon which the application and claims are based may bereadily utilized as a basis for the design of other structures, methods,and systems for carrying out the several purposes of the embodiments andclaims presented in this application. It is important, therefore, thatthe claims be regarded as including such equivalent constructions.

Furthermore, the purpose of the foregoing Abstract is to enable theUnited States Patent and Trademark Office and the public generally, andespecially including the practitioners in the art who are not familiarwith patent and legal terms or phraseology, to determine quickly from acursory inspection the nature and essence of the technical disclosure ofthe application. The Abstract is neither intended to define the claimsof the application, nor is it intended to be limiting to the scope ofthe claims in any way.

It should also be noted that, as used in the specification and theappended claims, the singular forms “a, an” and “the” include pluralreferences unless the context clearly dictates otherwise. References toa composition containing “a” constituent is intended to include otherconstituents in addition to the one named. Also, in describing thepreferred embodiments, terminology will be resorted to for the sake ofclarity. It is intended that each term contemplates its broadest meaningas understood by those skilled in the art and includes all technicalequivalents which operate in a similar manner to accomplish a similarpurpose.

Herein, the use of terms such as “having,” “has, including,” or“includes” are open ended and are intended to have the same meaning asterms such as “including” or “includes” and not preclude the presence ofother structure, material, or acts. Similarly, though the use of termssuch as “can” or “may” is intended to be open-ended and to reflect thatstructure, material, or acts are not necessary, the failure to use suchterms is not intended to reflect that structure, material, or acts areessential. To the extent that structure, material, or acts are presentlyconsidered to be essential, they are identified as such.

Further, used herein the terms “dentist,” “dental professional,”operator, clinician,’, and the like shall be interchangeable to refer toa person providing dental care or medical care or treating using thedisclosed systems, methods, or devices.

It is also to be understood that the mention of one or more method stepsdoes not preclude the presence of additional method steps or interveningmethod steps between those steps expressly identified. Moreover,although the term “step” may be used herein to connote different aspectsof methods employed, the term should not be interpreted as implying anyparticular order among or between various steps herein disclosed unlessand except when the order of individual steps is explicitly required.The components described herein as making up various elements of one ormore example embodiments are intended to be illustrative and notrestrictive. Many suitable components that would perform the same orsimilar functions as the components described herein are intended to beembraced within the scope of the invention. Such other components notdescribed herein can include, but are not limited to, for example,similar components that are developed after development of the presentlydisclosed subject matter.

What is claimed is:
 1. A method of producing a dental solution for a recipient, the method comprising: obtaining data descriptive of (i) a mandibular arch of the recipient, a maxillary arch of the recipient, or both the mandibular and maxillary arches, and (ii) one or more boundaries of a three-dimensional region; specifying a dental configuration for the recipient; parameterizing the dental configuration across the three-dimensional region to create a plurality of virtual dental solutions, each of the plurality of virtual dental solutions providing the specified dental configuration; and generating data that can be used to create at least one physical dental solution configured to provide specified dental configuration for the recipient, the at least one physical dental solution corresponding to one of the plurality of virtual dental solutions.
 2. The method of claim 1, wherein the physical dental solution comprises at least one from among a surgical guide, a restorative guide, a dental implant placement guide, a dental prosthetic, a denture, and a partial denture.
 3. The method of claim 2, wherein a surface of the three-dimensional region defines a maximum possible depth of the surgical guide, restorative guide, dental implant placement guide, dental prosthetic, denture, or partial denture.
 4. The method of claim 1, wherein the physical dental solution comprises at least two physical dental solutions from among a surgical guide, a restorative guide, a dental implant placement guide, a dental prosthetic, a denture, and a partial denture, the at least two physical dental solutions being corollaries to each other.
 5. The method of claim 1 further comprising: generating a virtual model of the maxillary arch, the mandibular arch, or both maxillary and mandibular arches, and positioning the specified dental configuration in virtual space within the virtual model.
 6. The method of to claim 1, wherein the boundary of the three-dimensional region comprises tissue surfaces of at least one of the mandibular arch and the maxillary arch.
 7. The method of to claim 1 wherein the boundary of the three-dimensional region comprises a region embedded within surfaces of at least one of the mandibular arch and the maxillary arch.
 8. The method of claim 1, wherein parameterizing the dental configuration comprises mathematically manipulating the dental configuration within the three-dimensional region to generate the plurality of virtual dental solutions.
 9. The method of claim 1, wherein the parameterizing comprises forming a series of virtual dental solutions designed to progressively correct damage of the recipient.
 10. The method of claim 1 further comprising attaching the dental configuration to one or more virtual points within virtual space.
 11. The method of claim 10, wherein the one or more virtual points relate to contact points of teeth of the recipient.
 12. The method of claim 11, wherein the plurality of virtual dental solutions is configured for adjusting a current contact point of teeth of the recipient towards the one or more virtual points to which the dental configuration is attached.
 13. The method of claim 11, wherein the plurality of virtual dental solutions is oriented using one or more virtual points within the three-dimensional region.
 14. The method of claim 1 further comprising instructing a three-dimensional printer to create to create the at least one physical dental solution based on the data.
 15. The method of claim 1, wherein the at least one physical dental solution comprises a retentive piece for one of the mandibular and maxillary arches comprising surfaces configured to interact with tissue of the other one of the mandibular and maxillary arches to provide the specified dental configuration.
 16. A system for producing a dental solution for a recipient comprising: a processor; memory storing instructions that, when executed by the processor, cause the system to: obtain data descriptive of (i) a mandibular arch of the recipient, a maxillary arch of the recipient, or both the mandibular and maxillary arches, and (ii) one or more boundaries of a three-dimensional region; specify a dental configuration for the recipient; parameterize the dental configuration across the three-dimensional region to create a plurality of virtual dental solutions, each of the plurality of virtual dental solutions providing the specified dental configuration; and generate data that can be used to create at least one physical dental solution configured to provide specified dental configuration for the recipient, the at least one physical dental solution corresponding to one of the plurality of virtual dental solutions.
 17. The system of claim 1, wherein the physical dental solution comprises at least one from among a surgical guide, a restorative guide, a dental implant placement guide, a dental prosthetic, a denture, and a partial denture.
 18. The system of claim 17, wherein a surface of the three-dimensional region defines a maximum possible depth of the surgical guide, restorative guide, dental implant placement guide, dental prosthetic, denture, or partial denture.
 19. The system of claim 1, wherein the physical dental solution comprises at least two physical dental solutions from among a surgical guide, a restorative guide, a dental implant placement guide, a dental prosthetic, a denture, and a partial denture, the at least two physical dental solutions being corollaries to each other.
 20. The system of to claim 1, wherein the boundary of the three-dimensional region comprises tissue surfaces of at least one of the mandibular arch and the maxillary arch. 